Multi-event January 2020 FDA Recall Drug by Preferred Pharmaceuticals, Inc
This Multi-event Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc on January 7, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0797-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
01-07-2020
01-29-2020
39,172 tablets
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.
Preferred Pharmaceuticals, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
12-14-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
Batch or Lot Expiration Information
Lot# : All lots within expiry
Recall Number: D-0796-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
01-07-2020
01-29-2020
221,710 tablets
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.
Preferred Pharmaceuticals, 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
12-14-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
Batch or Lot Expiration Information
Lot# : All lots within expiry
