Torrent Pharma Inc Recall: Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr
Torrent Pharma Inc Recall: Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Torrent Pharma Inc; Product: Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bott
| Recalling firm | Torrent Pharma Inc |
|---|---|
| Product | Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152. |
| Reason for recall | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States. |
| Recall initiated | 20190521 |
| Recall number | D-1369-2019 |
| Category | drug |
| State | PA |
| Country | United States |
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