FDA Drug recall D-1416-2015
Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class III recall of Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc by Silarx Pharmaceutical, citing 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 d….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1416-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-08-21 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Silarx Pharmaceutical |
| Distribution | US |
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
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).
Identifiers
| code_info | Lot # 0649A Exp. Date 05/18 (unit carton) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1416-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.