Why it was recalled
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product description
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01
Lot numbers, UPCs & expiration codes
Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020
Where it was sold
Distribution was made to CA and FL.
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-1410-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2019
- FDA report date
- Jun 26, 2019
- Quantity
- 192 4 oz bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-1410-2019, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83101
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020
- Postal code
- 92807-1801
- Report date
- Jun 26, 2019
- Product type
- Drugs
- Recall number
- D-1410-2019
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Product quantity
- 192 4 oz bottles
- Termination date
- Apr 3, 2023
- 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, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01
- Distribution pattern
- Distribution was made to CA and FL.
- Recall initiation date
- Jun 10, 2019
- Initial firm notification
- Center classification date
- Jun 20, 2019