Drug Enforcement D-0765-2023

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

Status

Completed

Classification

Class II

Report Date

May 31, 2023

Termination Date

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Product Information

Product description
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.
Product quantity
87,360 bottles
Reason for recall
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.

Location & Firm

Recalling firm
Aurobindo Pharma USA Inc.
Address
279 Princeton Hightstown Rd, N/A

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

Recall number
D-0765-2023
Event ID
92380
Recall initiation date
May 22, 2023
Center classification date
May 24, 2023
Code info
Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
More code info
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