Multi-event January 2020 FDA Recall Drug by Appco Pharma Llc
This Multi-event Class II drug recall was voluntarily initiated by Appco Pharma Llc on January 7, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0649-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
01-07-2020
01-15-2020
624 bottes
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.
Appco Pharma LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
04-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
Batch or Lot Expiration Information
Batch# 1905225VN, exp. date Apr-2021 1905226VD, exp. date Apr-2021 1906295UN, exp. date May-2021 1906296UN, exp. date May-2021 1906297UN, exp. date May-2021 1906298UD, exp. date May-2021
Recall Number: D-0648-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
01-07-2020
01-15-2020
1,632 bottes
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.
Appco Pharma LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
04-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
Batch or Lot Expiration Information
Batch# 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
