Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS results for known compound.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
Sun Pharmaceutical Industries
Class I - Dangerous
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Class I - Dangerous
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
West-Ward Pharmaceuticals
Class I - Dangerous
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Class I - Dangerous
Presence of Foreign Tablets/Capsules
Class I - Dangerous
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Class I - Dangerous
Superpotent
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
GSK Consumer Healthcare
Class I - Dangerous
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Class I - Dangerous
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Class I - Dangerous
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Amerisource Health Services
Class I - Dangerous
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Class I - Dangerous
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Class I - Dangerous
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
Wells Pharmacy Network
Class I - Dangerous
Superpotent and Subpotent drugs
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network
Wells Pharmacy Network
Class I - Dangerous
Superpotent and Subpotent drugs
Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Wells Pharmacy Network
Class I - Dangerous
Superpotent and Subpotent drugs
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.