Actavis Recalls
20 recalls on record · October 3, 2012 to March 15, 2017 · Drugs
Recalls by year
12
13
14
15
16
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 15, 2017DrugsFDA
Actavis Inc recalls Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal C
Hazard: Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
February 22, 2017DrugsFDA
Actavis Inc recalls Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cinci
Hazard: Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
February 1, 2017DrugsFDA
Actavis Inc recalls Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories In
Hazard: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
August 31, 2016DrugsFDA
Actavis Inc recalls Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B
Hazard: Failed 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).
August 31, 2016DrugsFDA
Actavis Inc recalls Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatla
Hazard: Failed 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).
August 24, 2016DrugsFDA
Actavis Inc recalls Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincin
Hazard: Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
August 3, 2016DrugsFDA
Actavis Inc recalls Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabet
Hazard: Failed Dissolution Specifications
July 1, 2015DrugsFDA
Actavis Inc recalls Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 2
Hazard: Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
March 11, 2015DrugsFDA
Actavis Inc recalls Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc.,
Hazard: Subpotent Drug
March 11, 2015DrugsFDA
Actavis Inc recalls Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc.,
Hazard: Subpotent Drug
November 5, 2014DrugsFDA
Actavis Inc recalls Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany,
Hazard: Subpotent Drug
November 5, 2014DrugsFDA
Actavis Inc recalls Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany,
Hazard: Subpotent Drug
June 25, 2014DrugsFDA
Actavis Inc recalls Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson
Hazard: Subpotent Drug.
March 5, 2014DrugsFDA
Actavis recalls Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell conta
Hazard: Subpotent Drug: Drug potency was compromised during shipment.
February 19, 2014DrugsFDA
Actavis Inc recalls Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose De
Hazard: Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
February 12, 2014DrugsFDA
Actavis Inc recalls Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc
Hazard: Failed Tablet/Capsule Specifications: Broken tablets
February 5, 2014DrugsFDA
Actavis Inc recalls BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count b
Hazard: Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
August 14, 2013DrugsFDA
Actavis Inc recalls BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Act
Hazard: Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
June 19, 2013DrugsFDA
Actavis recalls Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0
Hazard: Failed Impurities/Degradation Specifications
October 3, 2012DrugsFDA
Actavis recalls Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only
Hazard: Subpotent; some patches may not contain fentanyl gel