D-1416-2015 Class III Terminated
FDA drug recall D-1416-2015 was initiated by Silarx Pharmaceutical, Inc. on August 21, 2015 and is designated Class III. 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 lab… The recall status is terminated (terminated December 2, 2015). Affected quantity: 576 bottles.
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)