FDAFDA · Food and drugs·Recall number D-1410-2019
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
Published June 26, 2019 · Recall initiated: June 10, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Distributor
- Distribution was made to CA and FL.
- Lot
- Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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