August 2018 FDA Recall Doxycycline by American Health Packaging
D-1582-2019 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by American Health Packaging on August 1, 2018 for the product Doxycycline. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1582-2019
Failed Dissolution Specifications: Out of specification result for the dissolution test.
08-01-2018
08-07-2019
6,579 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
American Health Packaging
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
09-30-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
Batch or Lot Expiration Information
Lot# Lot 172569, Exp 7/31/2019
