Actavis

FDA Regulatory Profile

Summary

Total Recalls
20
510(k) Clearances
0
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0514-2017Class IIILevofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by February 7, 2017
D-0476-2017Class IIGlipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon PharmJanuary 30, 2017
D-0439-2017Class IIIAlbuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for WaJanuary 12, 2017
D-1471-2016Class IIIAcetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, ManufacturedAugust 2, 2016
D-1472-2016Class IIIHydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 August 2, 2016
D-1448-2016Class IIDextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured July 11, 2016
D-1457-2016Class IIGlipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon PharmaJune 30, 2016
D-1148-2015Class IIILutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet DJune 4, 2015
D-0406-2015Class IIVancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured forFebruary 12, 2015
D-0396-2015Class IIVancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured forFebruary 12, 2015
D-0232-2015Class IIVancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson PharAugust 25, 2014
D-0233-2015Class IIVancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson PharAugust 25, 2014
D-1386-2014Class IIVancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx OnlMay 16, 2014
D-1088-2014Class IIIGelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician samplFebruary 7, 2014
D-1085-2014Class IITrelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIDecember 9, 2013
D-1043-2014Class IIIBuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-333November 15, 2013
D-855-2013Class IIIBuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only,July 31, 2013
D-599-2013Class IIIFentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count syJune 3, 2013
D-1060-2014Class IIDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by WatsMarch 22, 2013
D-1693-2012Class IIFentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL July 11, 2012