March 2019 FDA Recall Drug by American Health Packaging
D-1820-2019 - Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.

This Class II drug recall was voluntarily initiated by American Health Packaging on March 1, 2019 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification result for an unknown impurity in stability samples.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1820-2019

Reason for Recall
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Initiated
03-01-2019
Reported
08-21-2019
Quantity
13,229 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83479
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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2020
Product Description About Product Description
Full technical description of the product.
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33

Batch or Lot Expiration Information

Lot# Lot, expiry: Lot 174262, exp. 03/31/2019; Lot 176469, exp. 06/30/2019; Lot 177897, exp. 08/31/2019; Lots 178318 and 178436, exp. 09/30/2019; Lot 179547 and 179656, exp. 11/30/2019