December 2023 FDA Recall Benzonatate by Amerisource Health Services Llc
D-0257-2024 - Superpotent drug
This Class III drug recall was voluntarily initiated by Amerisource Health Services Llc on December 26, 2023 for the product Benzonatate. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0257-2024
Superpotent drug: Assay results were slightly above specification at the time zero point.
12-26-2023
01-31-2024
6,344 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amerisource Health Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Batch or Lot Expiration Information
Lot# 1014208, Exp Mar/31/2025
