Why it was recalled
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Product description
Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16
Lot numbers, UPCs & expiration codes
Lot: 200N1601 Exp. 11/2018
Where it was sold
Nationwide.
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-1140-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 4149 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Centurion Labs, LLC
Original FDA data
Every field from FDA enforcement report D-1140-2017, exactly as published.
Show all FDA fields
- City
- Birmingham
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 77990
- Address
- 3100 Bowling Dr
- Address (line 2)
- Suite 1
- Code information
- Lot: 200N1601 Exp. 11/2018
- Postal code
- 35242-6588
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1140-2017
- Classification
- Class II
- Recalling firm
- Centurion Labs, LLC
- Product quantity
- 4149 bottles
- Termination date
- Sep 14, 2020
- Reason for recall
- Microbial contamination of Non-sterile Products; potential B. cepacia contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Press Release
- Center classification date
- Sep 12, 2017