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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
This recall involves Triaminic® Syrups and Theraflu Warming Relief® Syrups for coughs, colds and fevers. There are 24 types of these two products included in the recall. A complete list of products, lot numbers and National Drug Codes (NDC) can be found at www.novartisOTC.com. Lot numbers are located on the bottom panel of the box and on the left side of the label on the bottle. The NDC number is located on the upper right corner of the front panel of the Triaminic Syrups box and the upper left corner of the Theraflu Warming Relief Syrups bottle.
This recall only involves the following four products with the noted lot numbers: GNC Women's Ultra Mega 28-count multivitamin bottles with lot numbers 0432AL1781 and 1283CL1781, GNC Women's Ultra Mega Active 180-count multivitamin bottles with lot numbers 1029BL1783 and 1030BL1783, GNC Women's Ultra Mega Energy and Metabolism 90-count multivitamin bottles with lot number 1450CL1789 and GNC Prenatal Formula with Iron 120-count multivitamin bottles with lot number 0785BL2863. The lot numbers are printed on the side of the bottle and on the bottom of the product's packaging. The affected lots are packaged in a white plastic bottle with a white label and a flip-top cap.
The recalled supplements were sold in white plastic bottles. "Live Better Complete Multivitamin One Daily Maximum Formula" is printed in blue and red on a white label on one product and "Live Better Complex Vitamin B50" is printed in blue and green on a white label on the other product.
The recall involves Rugby Children's Pain & Fever Concentrated Drops (Acetaminophen Drops) in a 1/2 fl. oz. (15 ml) bottle size. The UPC code 305361936723 can be found with the bar code at the bottom of the box. The affected lot numbers are: 09002 09379 10272 10368 10487 09131 09394 10273 10406 11058 09215 10154 10366 10433 The lot numbers can be found stamped into the bottom of the carton with the expiration date and above the label on the bottle printed in black.
The recall involves Vicks Dayquil Cold & Flu 24-Count Bonus Pack Liquicaps. The medicine comes in orange packaging with the green Vicks symbol and has the following UPC#: 3 23900 01087 1. No other Vick's product is included in this recall.
The recalled supplements were sold in a brown plastic bottle. "Walgreens Finest High Potency Iron Supplement" is printed on the yellow and green label on the bottle.
The Nature's Bounty and Natural Wealth brand multivitamins have lot number 60835-06 written on the label. The recalled vitamins were sold in containers of 100 caplets. The containers are both clear with white caps. They are labeled "Nature's Bounty Multi-Day Multivitamin Plus Iron" or "Natural Wealth Daily Vitamin Plus Iron."
The recalled H.E.B. Super B-Complex vitamins with iron and 300 mg Vitamin C was sold in a container of 80 caplets. The white plastic bottle is labeled, "H.E.B. and Super B-Complex with Iron and 300 mg Vitamin C" and "Energy Metabolism" and has a blue lid.
The recalled Central Vite multivitamins were sold in a value size container of 500 tablets. The plastic white pill bottle is labeled "Advanced Formula Central Vite® with Lycopene" and "Value Size."
The product included in the recall is "Nature's Valley, Women's Formula Multivitamin." The supplement was sold in a brown plastic bottle with a light yellow label. The bottles have UPC code "0 41163 27006 0" located on the back of the bottle The recalled product is packaged in containers of 60 tablets and have green screw-on caps. Only bottles with lot numbers IFA2750 and IFA2751 are included in the recall. The lot numbers are written vertically down the back of the bottle.
Dietary Supplements Recalled by Sanapac NEWS from CPSC U.S. Consumer Product Safety Commission Office of Information and Public Affairs Washington, DC 20207 FOR IMMEDIATE RELEASE March 10, 1999 Release # 99-076 Company Phone Number: (800) 220-8180 CPSC Consumer Hotline: (800) 638-2772 CPSC Media Contact: Ken Giles, (301) 504-7052 CPSC, Sanapac Co. Announce Recall of Dietary Supplements WASHINGTON, D.C. - In cooperation with the U.S. Consumer Product Safety Commission (CPSC), The Sanapac Co., of Dallas, Pa., is voluntarily recalling about 140,000 bottles of dietary supplements containing elemental iron. The supplements being recalled are not packaged in child-resistant packaging as required under the Poison Prevention Packaging Act. If accidentally swallowed by children in toxic amounts, these supplements can cause serious injury or death. CPSC and Sanapac Co. are not aware of any injuries involving these products. This recall is being conducted to prevent the possibility of injury. The products involved are "Super Queens Inner Woman", "Super Kings Inner Man", "Sanapac Inner Man Gold", "Sanapac Rooster Brand Pills" and "Extra Strength Rooster Kings". The Sanapac company name and logo are on each bottle. The recalled products are packaged in containers of 30, 35, 60 and 70 tablets, all of which have traditional, screw-on caps. Pharmacies, health food, vitamin and grocery stores nationwide sold the supplements from January 1998 through December 1998 for about $6 to $20. Consumers should immediately return the products to the store where purchased for a refund or a child-resistant package. Consumers with questions about this recall should call Sanapac Co. at (800) 220-8180 between 9 a.m. and 5 p.m. EST Monday through Friday. Products sold since December 1998 are in child-resistant packages and are not involved in this recall.
November 8, 1993 Release # 94-009 PRODUCT: "Synergy Plus Chewables Vitabots" multiple vitamins and minerals. The product was promoted as a dietary supplement for children over four years of age. Each bottle of Vitabots has 90 light brown colored tablets; each tablet has five milligrams of iron. The supplements were sold nationwide in retail health food and nutrition stores between July 1, 1992 and July 31, 1993. PROBLEM: The product was not sold in child-resistant packaging as required by the Poison Prevention Packaging Act. The lack of child-resistant packaging means that a child could easily access and accidentally swallow the iron tablets. Each bottle of the product contains enough iron that, if consumed by a child at one time, it could cause serious illness requiring hospitalization. WHAT TO DO: Immediately return the unused portions of any bottles of the recalled Vitabots to the store where purchased for a refund of the purchase price. Consumers can also call the manufacturer at (201) 371-7300 for instructions on where to send the recalled products for a refund, including shipping costs. WASHINGTON, DC --- CPSC, International Vitamin Corp. (doing business as Synergy Plus), Union, NJ is voluntarily recalling its "SYNERGY PLUS (For Children Over 4 Years) CHEWABLES Vitabots Multiple Vitamins and Minerals with Digestive Enzymes and Oat Bran." This iron-containing vitamin and mineral supplement was not put in child-resistant packaging as required by the Poison Prevention Packaging Act. The lack of child-resistant packaging means that a child could easily access and accidentally swallow the iron tablets. Each bottle of the recalled product contains enough iron that, if consumed by a child at one time, it could cause serious illness requiring hospitalization. The recalled Vitabots Multiple Vitamins and Minerals (for children over 4 years) were sold in amber-colored glass bottles with white screw-on metal caps. Each bottle contains 90 light brown colored tablets with five milligrams (mg) of iron per tablet. The product, wrongly labeled "Non-Toxic," is promoted as a dietary supplement for children over four years of age. The bottle's label also carries the statement "Manufactured by SYNERGY PLUS, Union, N.J. 07083 USA." This recall does not include any other iron-containing products manufactured by International Vitamin Corp. Approximately 2,500 bottles of the recalled iron products were sold to consumers through retail health food and nutrition stores nationwide between July 1, 1992 and July 31, 1993 for approximately $9.00 - $10.00 per bottle. Consumers should immediately return the unused portions of any bottles of the recalled Vitabots to the store where purchased for a refund of the purchase price or call International Vitamin Corp. at 201-371-7300 for instructions on where to send the recalled products for a refund, including shipping costs. Neither International Vitamin Corp. nor the Commission is aware of any poisoning incidents involving the Synergy Plus brand of iron tablets. However, the Commission is aware of several ingestions and at least 25 deaths of children under five years from 1990 - 1992 from iron-containing products not manufactured by Synergy Plus, as reported by the American Association of Poison Control Centers. CPSC became aware of the packaging problem as a result of its ongoing poison prevention packaging inspection program. CPSC enforces the requirement that any dietary supplement containing an equivalent of 250 mg or more of iron per package must have child-resistant packaging. The U.S. Consumer Product Safety Commission is announcing this recall as part of its mission to protect the public from unreasonable risks of injury and death associated with consumer products. The Commission's mission is to reduce the estimated 28.6 million injuries and 21,700 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction
August 17, 1993 Release # 93-101 PRODUCT: Five iron-containing dietary supplement products manufactured and sold by Solgar Company, Inc. The products are: "Natural Amino Acid Chelated Iron," "Gentle Iron Vegicaps," "Hematinic Formula," "Prenatal Nutrients," and "Trace Elements." Approximately 17,500 bottles of the recalled products were sold in brown glass bottles with yellow screw-on caps between January 1, 1993 and mid-April 1993. The products were sold in health food and nutrition stores nationwide. PROBLEM: The products were not put in child-resistant packaging as required by the Poison Prevention Packaging Act. Even though the firm and CPSC know of no poisoning incidents due to the Solgar brand iron tablets and capsules, CPSC is aware of many ingestions and at least 11 deaths in 1991 from other iron-containing products. WHAT TO DO: Consumers with any of the recalled products should immediately return the unused portion of the bottles to the stores where purchased or return the product to Solgar Co., Inc. 410 Ocean Avenue, Lynbrook, NY 11563, Attention: Recall, for a complete refund of the purchase price plus postage. WASHINGTON, DC --- CPSC, Solgar Company, Inc. of Lynbrook, NY is voluntarily recalling five dietary supplement products containing iron. The products being recalled include all sized bottles of Solgar brand "Natural Amino Acid Chelated Iron," " Gentle Iron Vegicaps," "Hematinic Formula," "Prenatal Nutrients," and "Trace Elements." These five iron-containing products were not put in child-resistant packaging as required by the Poison Prevention Packaging Act. The lack of child-resistant packaging means that a child could easily access and accidentally swallow the iron tablets or capsules. Each bottle of the recalled products contains enough iron that, if consumed by a child at one time, could cause serious illness or death. The five recalled products were sold in brown glass bottles with yellow screw-on metal caps. Each product comes in several package sizes ranging from 50 to 1000 tablets or capsules per bottle. The bottles' paper labels read, in part: - "NATURAL AMINO ACID CHELATED* IRON . . . Sugar, Salt and Starch Free . . . VEGETARIAN FORMULA . . . 100 [or 250, 500, 1000] TABLETS . . . Each tablet provides Iron Amino Acid Chelate 300 mg equivalent to elemental Iron 30 mg." - "GENTLE IRON (IRON BISGLYCINATE) . . . 30 mg . . . NON- CONSTIPATING* . . . VEGETARIAN FORMULA . . . 90 [or 180] VEGICAPS . . . Each vegicap provides 175 mg of Iron Bisglycinate (Ferrochel) equivalent to 30 mg of elemental Iron." - "HEMATINIC FORMULA . . . CONTAINS THE BLOOD BUILDING FACTORS IRON, LIVER, VITAMIN B-12 and FOLIC ACID PLUS VITAMIN C . . . 100 [or 250] TABLETS . . . Each three tablets provide: Iron (Amino Acid Chelate**) . . . 45 mg, 250% of U.S. RDA." - "PRENATAL NUTRIENTS . . . Multi-Vitamin and Mineral Formula For Pregnant and Lactating Women . . . VEGETARIAN FORMULA . . . 60 [or 120] TABLETS . . . Four (4) tablets provide: Iron (chelate) . . . 45 mg." - "TRACE ELEMENTS . . . HYDROLYZED VEGETABLE MINERAL PROTEIN CHELATES AND COMPLEXES . . . VEGETARIAN FORMULA . . . 50 [or 100, 250] TABLETS . . . Each tablet provides: Iron (Hydrolyzed Protein Chelate) . . . 18 mg, 100% U.S. RDA." All of the bottles also carry the statement "Manufactured by The Solgar Vitamin Co. Inc., Lynbrook, NY 11563, U.S.A." This recall does not include any other products manufactured by Solgar which contain iron, nor does it include any of the above products packaged with the child-resistant white plastic "push-and-turn caps." Approximately 17,500 bottles of the five recalled iron products were sold to consumers through retail health food and nutrition stores nationwide between January 1, 1993 and mid-April 1993. These products were manufactured and sold by Solgar Co. Inc. for several years. Consumers should immediately return the unused portions of any bottles of the recalled iron products (including bottles which were purchased before January 1, 1993) to the stores where purchased for a refund of the purchase price. Or, consumers can return the recalled products directly to: Solgar Co., Inc., 410 Ocean Avenue, Lynbrook, NY 11563, Attention: Recall. Consumers will receive a refund, including shipping costs. Neither Solgar Co., Inc. nor the Commission is aware of any poisoning incidents due to the Solgar brand iron tablets or capsules. However, the Commission is aware of several ingestions and at least 11 deaths in 1991 from other iron-containing products, as reported by the National Association of Poison Control Centers. CPSC became aware of the packaging problem as a result of its ongoing poison prevention packaging inspection program. CPSC enforces the requirement that any dietary supplement containing an equivalent of 250 mg or more of iron per package must have child-resistant packaging. The U.S. Consumer Product Safety Commission is announcing this recall as part of its mission to protect the public from unreasonable risks of injury and death associated with consumer products. The Commission's mission is to reduce the estimated 28.6 million injuries and 21,700 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction
March 10, 1992 Release # 92-061 Chase Laboratories And Geneva Generics Recall Prenatal Vitamins With Folic Acid Due To Potential Iron Toxicity Hazard PRODUCT: "Prenatal Vitamins with Folic Acid" by Chase Laboratories under the Geneva Generics label, containing 100 tablets of vitamins with iron. PROBLEM: Lack of child-resistant closure means that a child could accidentally swallow these vitamins with iron. Just four or five tablets if consumed by a child at one time can cause serious illness or death. WHAT TO DO: Immediately return the "Prenatal Vitamins with Folic Acid" (100-tablet bottles) to the store where purchased for a refund of the purchase price. WASHINGTON, DC - In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Chase Laboratories, Inc. of Newark, NJ is voluntarily recalling their 100 tablet bottles of "Prenatal Vitamins with Folic Acid" packaged under the Geneva Generics label because they are not packaged with child-resistant closures. The product intended for pregnant or lactating women, contains 60 milligrams of iron per tablet. The iron contained in just four or five tablets, if consumed by a child at one time, can cause serious illness or death. The recalled Prenatal Vitamins contain 100 tablets with a total of 6,000 milligrams (mg) of iron. The package is not child-resistant as required by the Poison Prevention Packaging Act. The CPSC enforces the requirement that any over-the-counter medication or dietary supplement which contains more than 250 mg of iron in a single package must be supplied with child- resistant packaging. Chase Laboratories reported the packaging problem and their initiation of the recall to CPSC under the reporting requirements of Section 15(b) of the Consumer Product Safety Act, 15 U.S.C. {2064(b). Consumers should immediately return the product to the store where purchased for a refund of the purchase price. Since the product's introduction in 1990, approximately 70,000 bottles of Prenatal Vitamins with Folic Acid packaged under the Geneva Generics Label were distributed in non-child-resistant packaging through 342 retail and wholesale druggists nationwide. Chase Laboratories, the manufacturer, and Geneva Generics, the private label distributor, instituted the recall of this product because of the potential hazard to children from these tablets due to the lack of child- resistant packaging. Neither of the recalling firms nor the Commission is aware of any poisoning incidents due to this product. Data from the American Association of Poison Control Centers report that 11 children in the United States died in 1991 from ingestion of iron-containing medicines and dietary supplements. CPSC is announcing this recall as part of its mission to protect the public from unreasonable risks of injury and death associated with consumer products. The Commission's objective is to reduce the estimated 28.5 million injuries and 21,600 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction
December 12, 1978 Release # 78-104 Armour Replaces Safety Caps On Thyroid Tablets WASHINGTON, D.C. (Dec. 12) -- Armour Pharmaceutical Company and the U.S. Consumer Product Safety Commission (CPSC) today announced that Armour will replace the child-resistant caps on approximately 140,000 100-tablet bottles of prescription thyroid tablets. Efficacy and safety of the tablets themselves are not in question and no recall is involved. The firm voluntarily initiated the cap replacement program, which involves only those packages held in its warehouses, after Commission testing indicated that some adults might be unable to properly reclose the safety feature of the present package during use in the home. Regulations under the Poison Prevention Packaging Act currently require that at least 90% of those adults tested be able, not only to open the packages, but also to properly close them to protect young children from accidentally swallowing the contents. In addition to replacing caps on current inventory, Armour plans to continue its on-going safety packaging program to meet its own standards of quality and to assure compliance with CPSC regulations. In presenting this matter to the Commission, the staff acknowledged that upon receipt of the results of Commission testing, Armour promptly stopped distribution of the product in question and took immediate action to investigate and correct the problem