Class III · Low risk
Atropine Sulfate Ophthalmic 1% Solution
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
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
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk
Calcium Acetate Capsules
Presence of Foreign Tablets/Capsules
Class III · Low risk
BonaDur For Men
CGMP Deviations: not manufactured according to current good manufacturing practices.
Class III · Low risk
Fluoxetine Tablets USP
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Class III · Low risk
Azelastine HCl Nasal Solution
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Class III · Low risk
Klonopin (clonazepam)
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Class III · Low risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Class III · Low risk
NORCO (Hydrocodone Bitartrate and Acetaminophen)
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 75 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 25 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Atorvastatin Calcium Tablets 40 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 20 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 10 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Megestrol Acetate Oral Suspension
Subpotent Drug: Out of specification for assay (stability testing)
Class III · Low risk
Life Brand Clear Action Acne Treatment Concealer Stick
Superpotent drug: failed assay throughout the stick after 6 months stability.
Class III · Low risk
Cefuroxime
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class III · Low risk
Ultane (sevoflurane)
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Class III · Low risk
Oxycodone Hydrochloride Tablets
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Class III · Low risk
Ciclopirox Olamine Cream USP
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class III · Low risk
Vecuronium bromide for Injection
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity Specifications