Class II
Terminated
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
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- June 10, 2019
- Posted
- June 26, 2019
- Recall Number
- D-1410-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 192 4 oz bottles
- Firm Location
- Anaheim, CA, United States
Reason for Recall
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Distribution
Distribution was made to CA and FL.
Lot / Code Info
Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020
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