Drug Enforcement D-0647-2024

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

Status

Ongoing

Classification

Class II

Report Date

September 4, 2024

Termination Date

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Product Information

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.
Product quantity
266 bottles
Reason for recall
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
CA and NV

Location & Firm

Recalling firm
Preferred Pharmaceuticals, Inc.
Address
1250 N Lakeview Ave Ste O

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

Recall number
D-0647-2024
Event ID
95132
Recall initiation date
August 8, 2024
Center classification date
August 26, 2024
Code info
Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
More code info
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