Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product description
Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Lot numbers, UPCs & expiration codes
Lot #s: 17E016; 17E017, Exp. 05/2019; 17F023; 17F023A, Exp. 06/2019; 17L018; 17L029; 17L030; 17L031, Exp. 11/2019; 17M035, Exp. 12/2019; 18B002; 18B014; 18B035, Exp. 02/2020; 18C002; 18C019, Exp. 03/2020; 18D013, Exp. 04/2020.
Where it was sold
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1355-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 262,008 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc
Original FDA data
Every field from FDA enforcement report D-1355-2019, exactly as published.
Show all FDA fields
- City
- Levittown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 82889
- Address
- 2091 Hartel Ave
- Code information
- Lot #s: 17E016; 17E017, Exp. 05/2019; 17F023; 17F023A, Exp. 06/2019; 17L018; 17L029; 17L030; 17L031, Exp. 11/2019; 17M035, Exp. 12/2019; 18B002; 18B014; 18B035, Exp. 02/2020; 18C002; 18C019, Exp. 03/2020; 18D013, Exp. 04/2020.
- Postal code
- 19057-4506
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1355-2019
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc
- Product quantity
- 262,008 bottles
- Termination date
- Oct 6, 2020
- Reason for recall
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.
- Distribution pattern
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
- Recall initiation date
- May 21, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 13, 2019