Drug product
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
D-1416-2015
Product summary
- Event
- Event 71952
- Status
- Terminated
- Classification
- Class III
- Quantity
- 576 bottles
- Official record key
drug-enforcement:D-1416-2015
Official wording
Reason: 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).
Code information: Lot # 0649A Exp. Date 05/18 (unit carton)
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing