Silarx Pharmaceutical, Inc. recalls Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceutica…

Recall date

August 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1416-2015

FDA classification

Class III

Brand / firm

Silarx Pharmaceutical, Inc.

Sold / distributed

Nationwide

Why it was 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).

Class III means the product violates regulations but is not likely to cause harm.

What 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