Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
Coast Quality Pharmacy, LLC
Class I - Dangerous
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class I - Dangerous
Failed Content Uniformity Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
Breckenridge Pharmaceutical
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I - Dangerous
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Lack of Assurance of Sterility
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
Winder Laboratories
Class I - Dangerous
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Sagent Pharmaceuticals
Class I - Dangerous
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Class I - Dangerous
Defective Container
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Sagent Pharmaceuticals
Class I - Dangerous
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I - Dangerous
Defective Container
Class I - Dangerous
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Defective Container
Class I - Dangerous
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.