Drug product
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
D-310-2013
Product summary
- Event
- Event 64652
- Status
- Terminated
- Classification
- Class III
- Quantity
- 27,718 cases 16 count and 7,551 cases 576 count
- Official record key
drug-enforcement:D-310-2013
Official wording
Reason: Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
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,
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent