Actavis recalls
FDA enforcement reports naming Actavis as the recalling firm.
- Recall reports
- 20
- Class I (serious)
- 0
- Most recent report
- Mar 15, 2017
- Mar 15, 2017Levofloxacin Ophthalmic Solution, 0Drug · Actavis IncFailed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.Class III
- Feb 22, 2017Glipizide extended-release tablets, 2Drug · Actavis IncFailed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.Class II
- Feb 1, 2017Albuterol Sulfate Inhalation Solution, USP, 0Drug · Actavis IncFailed Impurities/Degradation Specifications: Product is out of specification for a known degradant.Class III
- Aug 31, 2016Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Act…Drug · Actavis IncFailed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).Class III
- Aug 31, 2016Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle,…Drug · Actavis IncFailed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).Class III
- Aug 24, 2016Glipizide 2Drug · Actavis IncFailed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.Class II
- Aug 3, 2016Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only…Drug · Actavis IncFailed Dissolution SpecificationsClass II
- Jul 1, 2015Lutera (0Drug · Actavis IncLabeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.Class III
- Mar 11, 2015Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Man…Drug · Actavis IncSubpotent DrugClass II
- Mar 11, 2015Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Man…Drug · Actavis IncSubpotent DrugClass II
- Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd
- Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd
- Vancomycin Hydrochloride Capsules, USP, 250 mg
- Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only
- Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-15…
- Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0
- BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle…
- BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bot…
- Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged…
- Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentany…
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