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Showing 3981–4000 of 14370 results

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Fentanyl Injection (SCA Pharmaceuticals) – Subpotency Risk (2020)

Subpotency: Out-of-specification stability test result for low potency was obtained.

FDANov 20, 2020IN, LA, MO• SCA Pharmaceuticals

CVS Health Hydrating Healing Ointment (US Pharmaceuticals) – Low Weight Fill (2020)

Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.

Class IIModerate

FDANov 19, 2020IN, RI• US Pharmaceuticals Inc.

Irinotecan Hydrochloride (Areva Pharmaceuticals) – CGMP Investigation (2020)

CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.

Class IIModerate

FDANov 19, 2020Nationwide• Areva Pharmaceuticals Inc

Aripiprazole Tablets (Harvard Drug) – Dissolution Failure (2020)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDANov 18, 2020Nationwide• The Harvard Drug Group

REGENECARE HA (MPM Medical) – Microbial Contamination (2020)

Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.

FDANov 17, 2020Nationwide• MPM Medical LLC

Dexmedetomidine HCl (Fresenius Kabi) – Cross Contamination (2020)

Cross Contamination with other products: trace amounts of lidocaine

FDANov 17, 2020Nationwide• Fresenius Kabi USA, LLC

Doxorubicin Hydrochloride (Fresenius Kabi) – Cross Contamination (2020)

Cross Contamination with Other Products: trace amounts of octreotide found during testing

FDANov 17, 2020Nationwide• Fresenius Kabi USA, LLC

Aripiprazole Tablets (Golden State Medical) – Dissolution Failure (2020)

FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets

Class IIModerate

FDANov 17, 2020Nationwide• Golden State Medical Supply Inc.

Kaiser Permanente Clotrimazole Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Athlete's Foot Cream (Taro) – Impurity Excess (2020)

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

Class IIModerate

FDANov 17, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

PHARMORIGINS CORE (Fusion Health) – unapproved additive (2020)

The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements

Class IIModerate

FDANov 17, 2020Nationwide• Fusion Health and Vitality LLC

Levocetirizine Tablets (InvaTech) – Stability Failure (2020)

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

FDANov 11, 2020Nationwide• InvaTech Pharma Solutions, LLC

Testosterone Gel (Teva) – Superpotent Medication (2020)

Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

FDANov 11, 2020Nationwide• Teva Pharmaceuticals USA

Aripiprazole Tablets (Apotex) – Dissolution Failure (2020)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDANov 11, 2020Nationwide• Apotex Corp.

Levetiracetam Tablets (EYWA) – Foreign Tablet Found (2020)

Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.

Class IIModerate

FDANov 10, 2020Nationwide• EYWA PHARMA INC

Clomipramine Capsules (Jubilant) – Specification Failure (2020)

Failed Tablet/Capsule Specification

Class IIModerate

FDANov 6, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Elderberry Herbal Extract (Quantum) – salmonella risk (2020)

Product recalled due to potential contamination of Salmonella.

FDANov 6, 2020IN, NJ, NY• Quantum Inc

Clobetasol Ointment (Teligent) – Potency Variation (2020)

Superpotent and Subpotent; low and high assay results

FDANov 5, 2020Nationwide• Teligent Pharma, Inc.

Triamcinolone Lotion (Teligent) – Subpotent Medication (2020)

Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.

FDANov 3, 2020Nationwide• Teligent Pharma, Inc.

Sodium Chloride Injection (Hikma) – pH Specification (2020)

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.

Class IIModerate

FDANov 3, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

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