D-1416-2015 Class III Terminated

Recalled by Silarx Pharmaceutical, Inc. — Carmel, NY

Recall Details

Product Type
Drugs
Report Date
September 9, 2015
Initiation Date
August 21, 2015
Termination Date
December 2, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
576 bottles

Product Description

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

Distribution Pattern

Nationwide

Code Information

Lot # 0649A Exp. Date 05/18 (unit carton)