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Cream (Dairy Farmers of America) - Sulfa Contamination (2014)

Two loads of raw milk shipped from Beaver Creek Farm located in Coopersville, MI tested positive for Supra Sulfa III (Sulfamethazine). One load was co-mingled with other loads of raw milk at the DFA facility in Adrian, MI and processed into cream and condensed skim milk. The second load went directly from the producers farm to Continental Dairy Facilities, LLC in Coopersville, Michigan and was fur

Class IIILow

FDAAug 21, 2014IL, MI, MO +1 more• Dairy Farmers of America

Candesartan Cilexetil/Hydrochlorothiazide Tablets (Apotex) – impurity risk (2014)

Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

Class IIILow

FDAAug 21, 2014

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Cream (Dairy Farmers of America) - Sulfa Contamination (2014)

Candesartan Cilexetil/Hydrochlorothiazide Tablets (Apotex) – impurity risk (2014)

ChiroThin Dietary Supplement (ChiroNutraceutical) – unapproved ingredients (2014)

Simvastatin 10 mg Tablets (Micro Labs) – impurity content (2014)

Nicotine Polacrilex Lozenge (Perrigo) – Dissolution Specification Failure (2014)

Biofire Defense: JBAIDS Instrument System Software version 3.5.0.72. Th...

Datascope Corporation: LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

ELITech Clinical Systems SAS: ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255,...

Rifampin Injection (Akorn) – Impurity Specification Failure (2014)

Depo-Medrol (Pfizer) – pH specification failure (2014)

Cataflam (Novartis) – illegible tablet markings (2014)

Rx CHOICE Liquid Vitamin C (Hi-Tech) – pH Specification Issue (2014)

Oxycodone Hydrochloride Oral Solution (Boehringer) – preservative failure (2014)

Original Marinade (Allegro) – Spoilage Risk (2014)

Diagnostica Stago, Inc.: Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA ...

BD Biosciences, Systems & Reagents: BD Multi Check CD4 Low Control Catalog No. 340916 is int...

Clonidine HCl Injection (X-Gen) – labeling error (2014)

AGFA Healthcare Corp.: Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 ...

Turkish Delight Rose (Turkana) – Unapproved Color (2014)

buPROPion HCl Extended-Release Tablets (Wockhardt) – Impurity Concerns (2014)