Home / Recalls / Actavis Inc / D-0476-2017

D-0476-2017 Class II Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
February 22, 2017
Initiation Date
January 30, 2017
Termination Date
March 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
499320 units

Product Description

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

Reason for Recall

Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Distribution Pattern

Nationwide in US

Code Information

Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/17; 3136782, Exp. 09/30/17; 3136903, 3136904, Exp.10/31/17; 3138250, Exp. 07/31/17; 3138968, Exp. 08/31/17; 3140000, Exp. 09/30/17

Other recalls by Actavis Inc

  • D-0514-2017 Class III — Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx On (February 7, 2017)
  • D-0439-2017 Class III — Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, (January 12, 2017)
  • D-1471-2016 Class III — Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL (August 2, 2016)
  • D-1472-2016 Class III — Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed (August 2, 2016)
  • D-1448-2016 Class II — Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, R (July 11, 2016)
  • D-1457-2016 Class II — Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufacture (June 30, 2016)
  • D-1148-2015 Class III — Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day (June 4, 2015)
  • D-0406-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx On (February 12, 2015)
  • D-0396-2015 Class II — Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx On (February 12, 2015)
  • D-0232-2015 Class II — Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, M (August 25, 2014)