FDA Drug recall D-0162-2016
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only
- FDA Drug
- Class III
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class III recall of RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only by Vintage Pharmaceuticals, citing failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0162-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-21 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vintage Pharmaceuticals |
| Distribution | US |
Product
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Reason
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Identifiers
| code_info | Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16. |
|---|
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-0162-2016%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.