Robafen DM recall: CGMP Deviations
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle…
Why was Robafen DM recalled?
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: J0218L, Batch: 10021812, Exp. 02/2020; Lot: L2718D, Batch numbers from consecutively from L2718D001 to L2718D096, Exp. 07/2020
- Product
- Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle…
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Quantity
- 192 4 oz bottles
- Distribution
- Distribution was made to CA and FL.
- Recall date
- June 26, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)