Multi-event November 2019 FDA Recall Drug by Avkare Inc.
This Multi-event Class II drug recall was voluntarily initiated by Avkare Inc. on November 14, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0525-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
11-14-2019
12-04-2019
104,797 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.
AVKARE Inc.
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.
10-27-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
Batch or Lot Expiration Information
Lot# Lots: a) 21307 Exp. 02/29/2020, 21309 Exp. 02/29/2020, 21528 Exp. 02/29/2020, 21527 Exp. 02/29/2020, 22247 Exp. 06/30/2020, 23214 Exp. 09/30/2020, 23243 Exp. 09/30/2020, 23244 Exp. 11/30/2020, 24198 Exp. 01/31/2021, 24199 Exp. 01/31/2021, 24289 Exp. 01/31/2021; b) 22291 Exp. 06/30/2020, 23215 Exp. 09/30/2020, 23776 Exp. 01/31/2021
Recall Number: D-0524-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
11-14-2019
12-04-2019
631,138 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.
AVKARE Inc.
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.
10-27-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
Batch or Lot Expiration Information
Lot# Lots: a) HK16617A Exp. 11/30/2019, HL03917A Exp. 11/30/2019, HL04017A Exp. 11/30/2019, HM06017A Exp. 11/30/2019, HM06117A Exp. 11/30/2019, HB03518A Exp. 03/31/2020, HB03618A Exp. 03/31/2020, HC14018A Exp. 04/30/2020, HC14118A Exp. 04/30/2020, HC14218A Exp. 04/30/2020, HC14318A Exp. 04/30/2020, HC14418A Exp. 04/30/2020, HC14518A Exp. 05/31/2020, HH04518A Exp. 08/31/2020, HH04618A Exp. 08/31/2020, HH04718A Exp. 08/31/2020, HH04818A Exp. 08/31/2020, HH04918A Exp. 08/31/2020, HK02718A Exp. 10/31/2020, HK06918A Exp. 10/31/2020, HL07418A Exp. 11/30/2020, HL07518A Exp. 11/30/2020, HA00419A Exp. 12/31/2020, HA00519A Exp. 12/31/2020, HA02719A Exp. 12/31/2020, HA02819A Exp. 12/31/2020, HA2719A Exp. 12/31/2020, HC05019A Exp. 03/31/2021, HC05119A Exp. 03/31/2021, HC05911A Exp. 03/31/2021, HE03319A Exp. 04/30/2021, HE03419A Exp. 04/30/2021, HE05419A Exp. 04/30/2021, HG02319A Exp. 06/30/2021, HG02419A Exp. 06/30/2021, HG02619A Exp. 06/30/2021; b) 21570 Exp. 03/31/2020, 21571 Exp. 03/31/2020, 22190 Exp. 03/31/2020, 22192 Exp. 05/31/2020, 22497 Exp. 05/31/2020, 22620 Exp. 05/31/2020, 22999 Exp. 09/30/2020, 23000 Exp. 09/30/2020, 24158 Exp. 03/31/2021, 24159 Exp. 04/30/2021; c) 21241 Exp. 03/31/2020, 21680 Exp. 03/31/2020, 22193 Exp. 03/31/2020, 22657 Exp. 03/31/2020, 23001 Exp. 09/30/2020, 23002 Exp. 09/30/2020, 24157 Exp. 04/30/2021
