Why it was recalled
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: 80053; 80055 Exp. 10/31/20
Where it was sold
Nationwide and Venezuela
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1297-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2019
- FDA report date
- May 22, 2019
- Quantity
- 33360 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unipharma, Llc.
Original FDA data
Every field from FDA enforcement report D-1297-2019, exactly as published.
Show all FDA fields
- City
- Tamarac
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 82754
- Address
- 10200 NW 67th St
- Code information
- Lots: 80053; 80055 Exp. 10/31/20
- Postal code
- 33321-6404
- Report date
- May 22, 2019
- Product type
- Drugs
- Recall number
- D-1297-2019
- Classification
- Class II
- Recalling firm
- Unipharma, Llc.
- Product quantity
- 33360 cartons
- Termination date
- Nov 25, 2020
- Reason for recall
- CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Venezuela
- Recall initiation date
- May 2, 2019
- Initial firm notification
- Letter
- Center classification date
- May 23, 2019