Preferred Pharmaceuticals Recalls Robafen DM Due to Potential Bacterial Contamination
Preferred Pharmaceuticals is recalling specific lots of Robafen DM cough syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential contamination with specific bacterial pathogens (Burkholderia cepacia and Ralstonia pickettii), which aligns with the rubric criteria for Severe severity involving significant health risks or Class II classifications with potential for harm.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling 192 bottles of Robafen DM, a generic cough and cold medication, due to potential contamination with Burkholderia cepacia and Ralstonia pickettii. The recalled product is a 118mL (4oz) bottle containing Dextromethorphan HBr and Guaifenesin. The recall is driven by Current Good Manufacturing Practice (CGMP) deviations that created a risk of microbial contamination.
The affected products are identified by Lot J0218L (Batch 10021812, Exp. 02/2020) and Lot L2718D (Batch numbers L2718D001 to L2718D096, Exp. 07/2020). Distribution was limited to California and Florida. Consumers should check their medication for these specific lot and batch numbers and expiration dates.
If you possess the recalled product, you should stop using it and contact your pharmacist or Preferred Pharmaceuticals for instructions on return or disposal. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- 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
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Category
- Drug — Cough and Cold
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: J0218L
- Batch: 10021812
- Exp. 02/2020
- Lot: L2718D
- Batch numbers from consecutively from L2718D001 to L2718D096
- Exp. 07/2020
Distribution
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