Class III · Low risk
Aptensio XR
Failed Dissolution Specification: Low dissolution outside of specifications
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
OraVerse (Phentolamine Mesylate)
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Class III · Low risk
Calendula Cream
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Class III · Low risk
Ferrous Sulfate 325 MG tablet
Presence of Foreign Tablets/Capsules
Class III · Low risk
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class III · Low risk
24-HOUR Oral Care q4 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
24-HOUR Oral Care q2 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
Chlorhexidine Gluconate Oral Rinse
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
Fabior (tazarotene)
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Class III · Low risk
Tramadol Hydrochloride 50 mg tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Indomethacin Capsules USP
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class III · Low risk
Triamcinolone Acetonide Lotion
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Class III · Low risk
Clocortolone Pivalate Cream
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Class III · Low risk
Decitabine for Injection
Failed impurities/degradation specifications: Failure to water content and impurity
Class III · Low risk
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Class III · Low risk
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Flucanazole Injection
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Class III · Low risk
Lynparza (olaparib)
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Class III · Low risk
labetalol HCl injection 20 mg/4 mL
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018