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.

Class I - Dangerous

💊 Drugs Recalled: May 21, 2019 Torrent Pharma Other Drugs

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Torrent Pharma Inc
Reason for Recall:: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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.