Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy...

FDA Recall #D-0647-2024 — Class II — August 8, 2024

Recall #D-0647-2024 Date: August 8, 2024 Classification: Class II Status: Ongoing

Product Description

Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.

Reason for Recall

Failed Impurities/Degradation Specifications - at 18-month Stability testing

Recalling Firm

Preferred Pharmaceuticals, Inc. — Anaheim, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

266 bottles

Distribution

CA and NV

Code Information

Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated