Drug Enforcement D-0646-2024

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

Status

Ongoing

Classification

Class II

Report Date

September 4, 2024

Termination Date

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Product Information

Product description
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
Product quantity
14940 bottles
Reason for recall
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Recall initiation reason
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Initial firm notification
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Distribution pattern
Nationwide in the USA and Puerto Rico

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0646-2024
Event ID
95098
Recall initiation date
August 6, 2024
Center classification date
August 26, 2024
Code info
a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.
More code info
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