Recalls / Class II
Class IID-1297-2019
Product
CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675
- Affected lot / code info
- Lots: 80053; 80055 Exp. 10/31/20
Why it was recalled
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Recalling firm
- Firm
- Unipharma, Llc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10200 NW 67th St, Tamarac, Florida 33321-6404
Distribution
- Quantity
- 33360 cartons
- Distribution pattern
- Nationwide and Venezuela
Timeline
- Recall initiated
- 2019-05-02
- FDA classified
- 2019-05-23
- Posted by FDA
- 2019-05-22
- Terminated
- 2020-11-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1297-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.