Recalls / Class II
Class IID-1410-2019
Product
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
- Affected lot / code info
- Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020
Why it was recalled
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 192 4 oz bottles
- Distribution pattern
- Distribution was made to CA and FL.
Timeline
- Recall initiated
- 2019-06-10
- FDA classified
- 2019-06-20
- Posted by FDA
- 2019-06-26
- Terminated
- 2023-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1410-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.