IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.

Recall Number: D-0644-2024

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20240904

Initiation Date: 20240806

Termination Date:

Reason for Recall

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Product Description

IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.

IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy&#x27;s Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.

Reason for Recall

Product Description

IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.