PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: September 9, 2015 Initiated: August 21, 2015 #D-1416-2015

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).

Details

Units Affected
576 bottles
Distribution
Nationwide
Location
Carmel, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Silarx Pharmaceutical, Inc.. Units affected: 576 bottles.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Drug on September 9, 2015. Severity: Low. Recall number: D-1416-2015.