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.
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
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
Class II · Moderate risk
DIPYRIDAMOLE Tablets USP
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Class II · Moderate risk
Persantine
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.