Why it was recalled
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
Product description
Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
Lot numbers, UPCs & expiration codes
16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13,
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-310-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 18, 2013
- FDA report date
- May 8, 2013
- Quantity
- 27,718 cases 16 count and 7,551 cases 576 count
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Reckitt Benckiser Inc
Original FDA data
Every field from FDA enforcement report D-310-2013, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64652
- Address
- 399 Interpace Parkway
- Code information
- 16 count: AG156 Exp 11/13, AG257 Exp 12/13, AH388 02/14, AJ167 03/14, AL367 Exp 05/14, AL555 & AL568 Exp 06/14, AM141 Exp 07/14. 576 Count: AK505 Exp 04/14, AK570 Exp 05/14, AH368 & AH398 Exp 02/14, AJ000 Exp 03/14, AG596 Exp 12/13,
- Postal code
- 07054
- Report date
- May 8, 2013
- Product type
- Drugs
- Recall number
- D-310-2013
- Classification
- Class III
- Recalling firm
- Reckitt Benckiser Inc
- Product quantity
- 27,718 cases 16 count and 7,551 cases 576 count
- Termination date
- Aug 14, 2014
- Reason for recall
- Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 18, 2013
- Initial firm notification
- Letter
- Center classification date
- May 1, 2013