May 2020 FDA Recall Doxycycline by American Health Packaging (D-1293-2020 - Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).)

This Class II drug recall was voluntarily initiated by American Health Packaging on May 19, 2020 for the product Doxycycline. The FDA reported the reason for recall as failed dissolution specification - dissolution results of 59% (spec. nlt 85%) at the 24 month time point (end of shelf life).. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1293-2020

Reason for Recall
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Initiated
05-19-2020
Reported
06-17-2020
Quantity
15,755 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85745
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-03-2022
Product Description About Product Description
Full technical description of the product.
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), 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# Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021

Affected Packages Involved in this Recall

62584-693-11 Doxycycline
62584-693-21 Doxycycline