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Showing 7061–7080 of 9558 results

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Test Cyp 200 (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Spiced Jelly Beans (Meijer) - undeclared Yellow #6 (2013)

Undeclared Allergen

32 oz bags of Meijer Spiced Jelly Beans contain undeclared Yellow # 6.

Class IIModerate

FDAMar 20, 2013IL, IN, KY +2 more• Meijer Distribution, Inc

Estradiol Valerate 20 mg/ml (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Cyclosporine Ophthalmic Drops (Clinical Specialties) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Estradiol Cypionate (Clinical Specialties) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Testosterone Estradiol Blend (Clinical Specialties) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Test Cyp-Estradiol Injection (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Test Cyp 50 mg-Estradiol Cyp 7 mg/ml (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Sodium Chloride 23.4% (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Cataract Drops (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

HCG Injection (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Hydroxyprogesterone (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Diazepam 5 mg/ml (Clinical Specialties) – Sterility Concerns (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Methylcobalamin High Dose (Clinical Specialties) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Progesterone Injection (Clinical Specialties) – Sterility Concern (2013)

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Class IIModerate

FDAMar 20, 2013FL, GA, SC• Clinical Specialties Compounding Pharmacy

Gerber Pure Water (Nestle Puerto Rico) - purification deficiency (2013)

An audit to the purified water supplier revealed deficiencies related to the Ozone purification system and particulates, the analytical results show that mold was found on one of the batches

FDAMar 19, 2013IN, PR• Nestle Puerto Rico Inc

LED Light Bulbs (Lighting Science Group) - fire hazard (2013)

The 120-volt LED bulbs, sold as 6- 8- and 9-watt bulbs (equivalent to 40 or 50 watts), were marketed under the brand names Definity, EcoSmart, Sylvania and Westinghouse. The model numbers A19, G25 and R20/PAR20 are found on the packaging and on the light-colored circular neck above the base of the bulb where the date code is also printed. The date code reflects the week and year of manufacture; for example date code L4010 was produced during the 40th week of 2010. The date codes listed below may have the letters "CH" or "MX" at the end. For example, date code L4010 can also appear as L4010CH or L4010MX. The date codes are: L4010 L4110 L4210 L4310 L4410 L4510 L4610 L4710 L4810 L4910 L5010 L5110 L5210 L5310 L0111 L0211 L0311 L0411 L0511 L0611 L0711 L0811 L0911 L1011 L1111

CPSCMar 19, 2013Nationwide• Citizen Electronics and Lighting Science Group

Cherry Cepacol Throat Lozenges (Reckitt Benckiser) – Subpotent Active Ingredient (2013)

Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.

FDAMar 18, 2013Nationwide• Reckitt Benckiser Inc

Dried Mango (S & M International) – undeclared sulfites (2013)

Undeclared Allergen

The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Dried Mango contains undeclared sulfites/preservatives.

Class IIModerate

FDAMar 15, 2013NY• S & M International Inc

Chinese Red Dates (S & M International) – unallowed dye (2013)

The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Red Dates contain unallowed dye basic violet 3.

FDAMar 15, 2013NY• S & M International Inc

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