Why it was recalled
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product description
Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
Lot numbers, UPCs & expiration codes
Lot #s: C04866; C09863, Exp. 10/19; F01267, Exp. 12/19; F12609, Exp. 2/20; F25327, Exp. 8/20.
Where it was sold
Nationwide in the U.S.
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-1408-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2019
- FDA report date
- Jun 26, 2019
- Quantity
- 17,664 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- P & L Developments, LLC
Original FDA data
Every field from FDA enforcement report D-1408-2019, exactly as published.
Show all FDA fields
- City
- Westbury
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83181
- Address
- 200 Hicks St
- Code information
- Lot #s: C04866; C09863, Exp. 10/19; F01267, Exp. 12/19; F12609, Exp. 2/20; F25327, Exp. 8/20.
- Postal code
- 11590-3323
- Report date
- Jun 26, 2019
- Product type
- Drugs
- Recall number
- D-1408-2019
- Classification
- Class II
- Recalling firm
- P & L Developments, LLC
- Product quantity
- 17,664 bottles
- Termination date
- Sep 9, 2020
- Reason for recall
- cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jun 5, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 20, 2019