Multi-event May 2022 FDA Recall Drug by Preferred Pharmaceuticals, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on May 3, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations- azido impurity levels observed to be above acceptable limits. The product was distributed in Within the U.S in FL and CA. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0892-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
05-03-2022
06-01-2022
47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Within the U.S in FL and CA.
09-21-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Batch or Lot Expiration Information
Lot# Lot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.
Recall Number: D-0891-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
05-03-2022
06-01-2022
31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Within the U.S in FL and CA.
09-21-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
Batch or Lot Expiration Information
Lot# Lot: K1721D, EXP: 4/30/2023, NDC: 68788-7758-09; Lot: K1021E, EXP: 7/31/2023, NDC: 68788-7758-09.
