Multi-event December 2019 FDA Recall Drug by Aaa Pharmaceutical, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Aaa Pharmaceutical, Inc. on December 26, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to one consignee who may have distributed the product further to their retail stores. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0645-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
12-26-2019
01-15-2020
34,272 (24-count 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.
AAA Pharmaceutical, 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.
Product was distributed to one consignee who may have distributed the product further to their retail stores.
03-10-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Batch or Lot Expiration Information
Lot# P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021
Recall Number: D-0646-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
12-26-2019
01-15-2020
31,536 (130-count 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.
AAA Pharmaceutical, 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.
Product was distributed to one consignee who may have distributed the product further to their retail stores.
03-10-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Batch or Lot Expiration Information
Lot# P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
