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Showing 11081–11100 of 14370 results

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E-Z-Gas Effervescent Granules (Bracco) – Subpotent Drug (2014)

Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

FDASep 18, 2014Nationwide• Bracco Diagnostic Inc

Xarelto (Janssen) – Microbial Contamination (2014)

Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

Class IIModerate

FDASep 17, 2014Nationwide• Janssen Ortho L.L.C.

Cranberry Macaroon Granola (NatureBox) – Incorrect Label (2014)

Firm discovered a pouch that had an incorrect back label. The front of the pouch was correctly labeled Cranberry Macaroon Granola but the back of the pouch was incorrectly labeled with the label for Cherry Berry Granola.

Class IIModerate

FDASep 17, 2014Nationwide• NatureBox, Inc.

Topiramate (Zydus) – Tablet Mix-up (2014)

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

Class IIModerate

FDASep 15, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Assured Aspirin (American Family) – Subpotent Tablets (2014)

Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.

Class IIModerate

FDASep 15, 2014CA, VA, WA• American Family Pharmacy, LLC

Tarceva (Astellas) – Dissolution Specification Failure (2014)

Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.

Class IIModerate

FDASep 15, 2014Nationwide• Astellas Pharma US Inc

CREON (AbbVie) – Foreign Tablets Mixed (2014)

Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

Class IIModerate

FDASep 15, 2014Nationwide• AbbVie Inc

Amiodarone HCl Injection (Mckesson) – Temperature Storage Issue (2014)

Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Class IIModerate

FDASep 12, 2014IN, MT, OR +1 more• Mckesson

MethylPREDNISolone Tablets (Qualitest) – Subpotent Medication (2014)

Subpotent; 6 month stability time point

FDASep 11, 2014Nationwide• Qualitest Pharmaceuticals

Heparin Sodium Injection (Hospira) – Particulate Matter Found (2014)

Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.

FDASep 11, 2014Nationwide• Hospira Inc.

Buprenorphine HCl Injection (Hospira) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.

Class IIModerate

FDASep 9, 2014Nationwide• Hospira Inc.

Potassium Chloride Injection (Baxter) – Product Mispack (2014)

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Class IIModerate

FDASep 8, 2014Nationwide• Baxter Healthcare Corp

Glutathione Injection (Pharmacy Creations) – Non-Sterile Risk (2014)

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

FDASep 5, 2014FL, IN, NJ +2 more• Pharmacy Creations

Ophthalmic Solution (Pharmacy Creations) – Non-Sterile Risk (2014)

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

FDASep 5, 2014FL, IN, NJ +2 more• Pharmacy Creations

Ascorbic Acid Injection (Pharmacy Creations) – Non-Sterile Risk (2014)

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

FDASep 5, 2014FL, IN, NJ +2 more• Pharmacy Creations

Magnesium Chloride Injection (Pharmacy Creations) – Non-Sterile Risk (2014)

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

FDASep 5, 2014FL, IN, NJ +2 more• Pharmacy Creations

Bupivacaine HCl Injection (Hospira) – Particulate Contamination (2014)

Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.

Class IIModerate

FDASep 4, 2014Nationwide• Hospira Inc.

Oxycodone-Acetaminophen Tablets (Alvogen) – Dosage Uniformity Issue (2014)

Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.

Class IIModerate

FDAAug 28, 2014Nationwide• Alvogen, Inc

Fluocinonide Gel (Fougera) – Stability Specification Failure (2014)

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

Class IIModerate

FDAAug 28, 2014Nationwide• Fougera Pharmaceuticals Inc.

Dermatend Original (Solace International) – Unapproved Claims (2014)

Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.

Class IIModerate

FDAAug 28, 2014Nationwide• Solace International Inc

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