Presence of yeast and potential contamination with B. cepacia.
All Recalls
95,075 total recalls in our database
During sanitation activities it was noticed that two light shields had pieces missing and potentially could have gotten into finished products.
Presence of yeast and potential contamination with B. cepacia.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Microbial Contamination of Non-Sterile Products.
BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
BotanicalNow
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
www.blankterrmall.com
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Subpotent
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Lack Of Assurance Of Sterility
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
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.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).