Reckitt Benckiser Recalls Cherry Cepacol Sore Throat Lozenges for Low Benzocaine
Reckitt Benckiser is recalling Cherry Cepacol Sore Throat Lozenges because the active ingredient, benzocaine, did not meet stability specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Reckitt Benckiser Inc is recalling Cherry Cepacol Sore Throat Lozenges containing Benzocaine 15 mg and Menthol 3.6 mg. The recall covers 16-count and 576-count packages distributed nationwide. The specific reason for the recall is that the product did not conform to the 18-month stability test specification for active Free Benzocaine, meaning the product is subpotent.
The affected products include 27,718 cases of the 16-count version and 7,551 cases of the 576-count institutional size. Specific lot codes and expiration dates are listed in the recall notice, including codes such as AG156, AG257, and AH388 for the 16-count items, and AK505, AK570, and AH368 for the 576-count items.
Consumers with these products should stop using them and contact Reckitt Benckiser for a refund or replacement. The FDA has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- 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
- Manufacturer
- Reckitt Benckiser Inc
- Category
- Drug — OTC Sore Throat Lozenges
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distributed nationwide across the United States.
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