Class I - Dangerous
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Lack Of Assurance Of Sterility
Class I - Dangerous
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
Mylan Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class I - Dangerous
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class I - Dangerous
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
Pharmedium Services
Class I - Dangerous
Superpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Class I - Dangerous
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class I - Dangerous
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Hetero Labs, Ltd. - Unit III
Class I - Dangerous
Presence of foreign substance: metallic razor blade was found in one bottle.
Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.