Class III · Low risk
Virt-Advance Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Novacort Gel Sample Packets
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Class III · Low risk
INOVA (benzoyl peroxide)
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Class III · Low risk
Endure 400 Scrub-Stat
Subpotent Drug
Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class III · Low risk
Risedronate Sodium Delayed-release Tablets
Failed Dissolution Specifications
Class III · Low risk
Protonix I.V.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Class III · Low risk
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick
Labeling: Label Mix Up- Incorrect back label applied to the product.
Class III · Low risk
Sodium Ferric Gluconate Complex in Sucrose Injection
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class III · Low risk
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation
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
Amoxicillin for Oral suspension
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
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications: OOS results for known compound.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 6 month time point
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
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 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 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