Multi-event February 2020 FDA Recall Drug by American Health Packaging

This Multi-event Class II drug recall was voluntarily initiated by American Health Packaging on February 7, 2020 for the product Drug. The FDA reported the reason for recall as gmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0848-2020 TERMINATED D-0849-2020 TERMINATED

Recall Number: D-0848-2020

Reason for Recall
GMP Deviations: Product bottle may be absent of desiccant.
Initiated
02-07-2020
Reported
02-26-2020
Quantity
1,879 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84990
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.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11

Batch or Lot Expiration Information

Lot# Lot 181109, exp 4/30/2020

Recall Number: D-0849-2020

Reason for Recall
GMP Deviations: Product bottle may be absent of desiccant.
Initiated
02-07-2020
Reported
02-26-2020
Quantity
3,720 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84990
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.
08-04-2022
Product Description About Product Description
Full technical description of the product.
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11

Batch or Lot Expiration Information

Lot# Lot 180510, exp 3/31/2020; Lot 181912, exp 4/30/2020