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 Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
Lot numbers, UPCs & expiration codes
Lots: 80043 Exp. 07/05/20; 80047 Exp. 07/31/20
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-1302-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2019
- FDA report date
- May 22, 2019
- Quantity
- 38640 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unipharma, Llc.
Original FDA data
Every field from FDA enforcement report D-1302-2019, 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: 80043 Exp. 07/05/20; 80047 Exp. 07/31/20
- Postal code
- 33321-6404
- Report date
- May 22, 2019
- Product type
- Drugs
- Recall number
- D-1302-2019
- Classification
- Class II
- Recalling firm
- Unipharma, Llc.
- Product quantity
- 38640 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 Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
- Distribution pattern
- Nationwide and Venezuela
- Recall initiation date
- May 2, 2019
- Initial firm notification
- Letter
- Center classification date
- May 23, 2019