Home / Recalls / Sandoz Incorporated / D-268-2013

D-268-2013 Class II Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
May 1, 2013
Initiation Date
April 18, 2013
Termination Date
February 26, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8286 x 30 ct, 37108 x 500 ct. bottles

Product Description

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

Reason for Recall

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

Distribution Pattern

Nationwide

Code Information

CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15

Other recalls by Sandoz Incorporated

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  • D-0943-2017 Class III — Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781- (June 16, 2017)
  • D-0236-2017 Class II — Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured (December 22, 2016)
  • D-0291-2015 Class III — Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz (December 5, 2014)
  • D-1509-2014 Class II — Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, (July 25, 2014)
  • D-383-2014 Class II — Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in (October 22, 2013)
  • D-66373-001 Class III — Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle (September 25, 2013)
  • D-854-2013 Class III — Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, (August 7, 2013)
  • D-805-2013 Class II — Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X2 (June 21, 2013)
  • D-597-2013 Class II — Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, singl (May 30, 2013)