Class III · Low risk Terminated
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick
Reason Labeling: Label Mix Up- Incorrect back label applied to the product.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Sodium Ferric Gluconate Complex in Sucrose Injection
Reason Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class III · Low risk Terminated
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Class III · Low risk Terminated
Amoxicillin for Oral suspension
Reason Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Class III · Low risk Terminated
Diltiazem HCl Extended-release Capsules
Reason Failed Impurities/Degradation Specifications: OOS results for known compound.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications; 6 month time point
Class III · Low risk Terminated
Qnasl
Reason Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class III · Low risk Terminated
Qnasl
Reason Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class III · Low risk Terminated
Kenalog
Reason Failed Stability Specifications: Low Out of Specification results for alcohol content.
Class III · Low risk Terminated
Bupropion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Class III · Low risk Terminated
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
Reason 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 Terminated
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
Reason 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 Terminated
Ceftriaxone for Injection
Reason Labeling: Missing Label
Class III · Low risk Terminated
Invokamet
Reason 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 Terminated
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx…
Reason Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Class III · Low risk Terminated
Zeasorb AF
Reason 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 Terminated
Olanzapine tablets
Reason 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 Terminated
AHP NIFEdipine Capsules
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial
Reason 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 Terminated
Testosterone Cypionate 200 mg/mL in Sesame Oil
Reason 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 III · Low risk Terminated
NIFEdipine Capsules USP
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Class III · Low risk Terminated
Clonazepam Tablets
Reason Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Class III · Low risk Terminated
Clonazepam Tablets
Reason Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Class III · Low risk Terminated
PARICALCITOL Capsules
Reason Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.