NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01.
Acella Pharmaceuticals
Class I - Dangerous
Superpotent Drug.
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Prescription Drugs
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Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Failed dissolution specifications
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
West-Ward Columbus
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Class I - Dangerous
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Class I - Dangerous
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50
Mylan Institutional
Class I - Dangerous
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Class I - Dangerous
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class I - Dangerous
Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
Class I - Dangerous
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Amneal Pharmaceuticals of New York
Class I - Dangerous
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class I - Dangerous
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
Dr. Reddy's Laboratories
Class I - Dangerous
Discoloration: product contains brown pellets
Class I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.
Class I - Dangerous
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Class I - Dangerous
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Class I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.