CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
Morton Grove Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class I - Dangerous
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Class I - Dangerous
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class I - Dangerous
Lack of processing controls
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
Meitheal Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Prescription Labs Inc
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Superpotent Drug
Class I - Dangerous
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01
Rhodes Pharmaceuticals, L.P.
Class I - Dangerous
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Presence of foreign matter
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Subpotent
Class I - Dangerous
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Class I - Dangerous
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Class I - Dangerous
Non-Sterility: firm's third party lab confirmed microbial contamination.