FDA Drug recall D-1484-2014
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratorie…
- FDA Drug
- Class III
- terminated
- Published 2014-09-03
On 2014-09-03 the FDA classified a Class III recall of Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratorie… by Novel Laboratories, citing failed Impurity/Degradation Specification; 12-month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1484-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-06-20 |
| Published | 2014-09-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novel Laboratories |
| Distribution | US |
Product
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Reason
Failed Impurity/Degradation Specification; 12-month stability time point
Identifiers
| ndc | 43386-500-11 |
|---|---|
| code_info | Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016. |
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-1484-2014%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.