August 2024 FDA Recall Drug by Preferred Pharmaceuticals, Inc.
D-0647-2024 - Failed Impurities/Degradation Specifications - at 18-month Stability testing
This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on August 8, 2024 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications - at 18-month stability testing. The product was distributed in CA and NV and the recall is currently ongoing.
Recall Number: D-0647-2024
Failed Impurities/Degradation Specifications - at 18-month Stability testing
08-08-2024
09-04-2024
266 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.
Ongoing
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CA and NV
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Batch or Lot Expiration Information
Lot# Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
