FDA Drug recall D-0809-2016
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc.,…
- FDA Drug
- Class III
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class III recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc.,… by Bio Pharm, citing failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0809-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-12-17 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bio Pharm |
| Distribution | US |
Product
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Reason
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Identifiers
| code_info | Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15…Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017 |
|---|
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-0809-2016%22
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