Multi-event January 2020 FDA Recall Drug by Teva Pharmaceuticals Usa
This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on January 27, 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
Recall Number: D-0830-2020
GMP Deviations: Product bottle may be absent of desiccant.
01-27-2020
02-12-2020
22,868 bottles
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.
Teva Pharmaceuticals USA
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 within the United States
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
Batch or Lot Expiration Information
Lot# : 1281203M, exp. date 03/2020 and 1290113M, exp. date 04/2020
Recall Number: D-0831-2020
GMP Deviations: Product bottle may be absent of desiccant.
01-27-2020
02-12-2020
69,012 bottles
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.
Teva Pharmaceuticals USA
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 within the United States
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
Batch or Lot Expiration Information
Lot# : 1269726M, exp. date 01/2020; 1283269M, 1283270M, exp. date 03/2020; 1292992M,1292993A, exp. date 04/2020
