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Showing 3141–3160 of 3363 results

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TEV-TROPIN Injection (Ferring) – Label Mix-up (2013)

Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A

FDAFeb 1, 2013Nationwide• Ferring Pharmaceuticals Inc

Suprax Cefixime (Lupin) – Color Specification Issue (2013)

Discoloration; Product may not meet specifications for color description once reconstituted.

FDAJan 31, 2013Nationwide• Lupin Pharmaceuticals Inc.

Methocarbamol Tablets (Stat Rx USA) – Incorrect Labeling (2013)

Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.

Class IIILow

FDAJan 28, 2013PA• Stat Rx USA

Salted Black Beans (Mandalay) – Pathogen Growth Risk (2013)

Mandalay Trading is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.

FDAJan 25, 2013CA, GA, NV +3 more• Mandalay Trading Corporation

Sodium Sulfacetamide Lotion (Mission Pharmacal) – Superpotent (2013)

Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.

FDAJan 23, 2013Nationwide• Mission Pharmacal Co

Crest Pro-Health Oral Rinse (P&G) – Product Contamination (2013)

Cross Contamination with Other Products: Product was mixed with another type of mouth wash.

FDAJan 23, 2013Nationwide• Procter & Gamble Hair Care Llc

Syeda Tablets (Sandoz) – Incorrect Tablet Imprint (2013)

Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

FDAJan 22, 2013Nationwide• Sandoz Incorporated

Sugar Snap Peas (Mann's) – Pesticide Contamination (2013)

California Department of Food and Agriculture randomly sampled Sunny Shores Mann's snap peas and found them to contain 0.278 and 0.195 ppm of Carbendazim. Carbendazim is a pesticide that is not allowed in the US but is approved for use in the EU>

FDAJan 19, 2013AL, AZ, CA +13 more• Mann Packing Co Inc

Rite Aid Tussin Cough & Cold (Aaron) – Ingredient Precipitation (2013)

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

FDAJan 18, 2013Nationwide• Aaron Industries Inc

Equate Tussin CF Adult (Aaron) – Ingredient Precipitation (2013)

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

FDAJan 18, 2013Nationwide• Aaron Industries Inc

Walgreens Wal-Tussin CF Max (Aaron) – Ingredient Precipitation (2013)

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

FDAJan 18, 2013Nationwide• Aaron Industries Inc

Select Brand Cough Control CF Max (Aaron) – Ingredient Precipitation (2013)

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

FDAJan 18, 2013Nationwide• Aaron Industries Inc

MET-Rx EXTREME NOS PUMPED Watermelon (NBTY) – quality issue (2013)

The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage.

FDAJan 18, 2013Nationwide• NBTY Inc.

Tausi Salted Black Beans (Phil-Am Trading) – botulinum risk (2013)

This recall has been initiated due to suspected but, as of the writing of this letter (1/17/2013), unconfirmed Clostridium botulinum (C. botulinum) contamination.

FDAJan 18, 2013IN, NJ, NY +1 more• Phil-Am Trading, Inc.

MET-Rx EXTREME NOS PUMPED Nitro-Punch (NBTY) – quality issue (2013)

The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage.

FDAJan 18, 2013Nationwide• NBTY Inc.

Tausi Salted Black Beans (Golden Dharma) – pathogen potential (2013)

Golden Dharma International is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.

FDAJan 18, 2013CA, NJ• Golden Dharma International Corp

MET-Rx EXTREME NOS PUMPED Double Berry (NBTY) – quality issue (2013)

The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage.

FDAJan 18, 2013Nationwide• NBTY Inc.

Tausi Salted Black Beans (Walong) – pathogen potential (2013)

Walong is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.

FDAJan 17, 2013Nationwide• Walong Marketing, Inc.

Tausi Salted Black Beans (G.L. Food) – pathogen potential (2013)

GL Food Wholesale is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.

FDAJan 16, 2013AZ, CA, IL +6 more• G.L. Food Wholesale Inc

Ventavis Inhalation Solution (Actelion) – Subpotent Drug (2013)

Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.

FDAJan 16, 2013CA, VA• Actelion Pharmaceuticals U.S., Inc.

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