FDA Drug recall D-1351-2019
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bo…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bo… by Torrent Pharma, citing cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1351-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-21 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Identifiers
| code_info | Lot #s: a) 17F001, Exp. 06/2019; 17G016, Exp. 07/2019; 17H017, Exp. 08/2019;17L002; 17L024, Exp. 11/2019; 17M010; 17M01…Lot #s: a) 17F001, Exp. 06/2019; 17G016, Exp. 07/2019; 17H017, Exp. 08/2019;17L002; 17L024, Exp. 11/2019; 17M010; 17M013, Exp. 12/2019; 18B006; 18B031, Exp. 02/2020; 18C033, Exp. 03/2020; 18D015; 18D016, Exp. 04/2020; 18E020, Exp. 05/2020; 18G013, Exp. 07/2020; 18L010, Exp. 11/2020; 19A010; 19A019, Exp. 01/2021 b) 17F015, Exp. 06/2019; 17L009, Exp. 11/2019; 17M012, Exp. 12/2019; 18B015, Exp. 02/2020; 18C034, Exp. 03/2020; 18E026, Exp. 05/2020; 18G011, Exp. 08/2020. c) 17E014, Exp. 05/2019; 17G009;17G020, Exp. 07/2019; 17K019, Exp. 10/2019; 17L012; 17L013, Exp. 11/2019; 17M016; 17M033, Exp. 12/2019; 18A002, Exp. 01/2020; 18B009; 18B019, Exp. 02/2020; 18C015; 18C035, Exp. 03/2020; 18D001; 18D002, Exp. 04/2020; 18E018, Exp. 05/2020; 18F027, Exp. 06/2020; 18H017; 18H018, Exp. 08/2020; 18K016; 18K035, Exp. 10/2020. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1351-2019%22
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