Robafen DM Syrup recall: CGMP Deviations
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.
Why was Robafen DM Syrup recalled?
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- Torrent Pharma Inc
- Quantity
- 1,500,672 bottles
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Recall date
- June 19, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)