Home / Recalls / Impax Laboratories, Inc. / D-0215-2017

D-0215-2017 Class I Terminated

Recalled by Impax Laboratories, Inc. — Hayward, CA

Recall Details

Product Type
Drugs
Report Date
December 28, 2016
Initiation Date
August 19, 2016
Termination Date
June 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,074 boxes (30 count boxes)

Product Description

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA

Reason for Recall

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

Distribution Pattern

Distributed Nationwide

Code Information

Lot Number 502240, expiry date 11/2017

Other recalls by Impax Laboratories, Inc.

  • D-0820-2016 Class III — Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed (March 17, 2016)
  • D-0821-2016 Class III — Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed (March 17, 2016)
  • D-0826-2016 Class II — Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufact (March 14, 2016)
  • D-0825-2016 Class II — Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufac (March 14, 2016)