Class II · Moderate risk
Salsalate Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
KENALOG (Triamcinolone Acetonide)
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Class III · Low risk
Bupropion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Indiomin MB URINARY ANTISEPTIC
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
AZUPHEN MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
UROPHEN MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
URAMIT MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Urolet Mb Urinary Antiseptic
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Hyolev MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Sodium Chloride Ophthalmic Solution
Subpotent Drug: concentration of product is less than labeled amount.
Class III · Low risk
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
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 III · Low risk
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
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 II · Moderate risk
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Class III · Low risk
Ceftriaxone for Injection
Labeling: Missing Label
Class III · Low risk
Invokamet (canagliflozin and metformin HCl)
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Class III · Low risk
HCG (Chorionic Gonadotropin Lyopholized)
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Class III · Low risk
Zeasorb AF
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 III · Low risk
Olanzapine tablets
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Class III · Low risk
AHP NIFEdipine Capsules
Presence of Foreign Tablets/Capsules
Class III · Low risk
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Class III · Low risk
Testosterone Cypionate 200 mg/mL in Sesame Oil
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Class II · Moderate risk
Succinylcholine Chloride
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Class III · Low risk
NIFEdipine Capsules USP
Presence of Foreign Tablets/Capsules