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 Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368
Lot numbers, UPCs & expiration codes
Lots: 80054; 80056 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-1306-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2019
- FDA report date
- May 22, 2019
- Quantity
- 21456 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unipharma, Llc.
Original FDA data
Every field from FDA enforcement report D-1306-2019, 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: 80054; 80056 Exp. 10/31/20
- Postal code
- 33321-6404
- Report date
- May 22, 2019
- Product type
- Drugs
- Recall number
- D-1306-2019
- Classification
- Class II
- Recalling firm
- Unipharma, Llc.
- Product quantity
- 21456 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 Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368
- Distribution pattern
- Nationwide and Venezuela
- Recall initiation date
- May 2, 2019
- Initial firm notification
- Letter
- Center classification date
- May 23, 2019