Reported Jun 26, 2019 · Terminated
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP…
Preferred Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Preferred Pharmaceuticals, Inc · 1250 N Lakeview Ave Ste O · Anaheim, CA · 92807-1801
Is this the product you have?
- 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 codes and dates
- LotJ0218L
- Batch
10021812Exp. 02/2020
- LotL2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020
- Amount recalled
- 192 4 oz bottles
Where it was sold
Why it was recalled
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
This product could cause temporary or reversible health problems — stop using it.
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