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Orphenadrine Citrate Extended Release Tablets (Sandoz) – Dissolution Failure (2014)

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

FDAJul 11, 2014Nationwide• Sandoz Inc

Viracept Tablets (Pfizer) – Labeling Error (2014)

Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.

Class IIILow

FDAJul 8, 2014Nationwide• Pfizer Inc.

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Orphenadrine Citrate Extended Release Tablets (Sandoz) – Dissolution Failure (2014)

Viracept Tablets (Pfizer) – Labeling Error (2014)

Shell Eggs (Michael Foods) – Bacterial Contamination (2014)

Triamcinolone Acetonide Lotion 0.025% (Fougera) – pH Specification Issue (2014)

Diltiazem HCl Extended-release Capsules (Mylan) – Impurity Specification Failure (2014)

Triamcinolone Acetonide Lotion 0.1% (Fougera) – pH Specification Issue (2014)

E-Z-HD Barium Sulfate (Bracco) – Subpotent Drug Concerns (2014)

Poly-Tussin AC Liquid (Poly Pharmaceuticals) – Monograph Deviation (2014)

Lortuss EX Liquid (Poly Pharmaceuticals) – Monograph Deviation (2014)

Frosted Flakes (mom Brands) – Mislabeling Issue (2014)

Famotidine Oral Suspension (Novel Laboratories) – Stability Failure (2014)

Hana Ebi Green Shrimp Flakes (Modern Macaroni) – Sulfite Excess (2014)

Hana Ebi Red Shrimp Flakes (Modern Macaroni) – Sulfite Excess (2014)

Tolterodine Tartrate Tablets (Mylan) – Impurity Specification Failure (2014)

Diltiazem HCl Extended Release Capsules (Mylan) – Compound Failure (2014)

Cardura XL (Pfizer) – Degradation Specification Failure (2014)

Aspirin DR Enteric Coated Tablets (Mckesson) – Dissolution Failure (2014)

Velivet (Teva) – Impurity Specification Failure (2014)

Kariva (Teva) – Impurity Specification Failure (2014)

Apri (Teva) – Impurity Specification Failure (2014)