Drug Enforcement D-0471-2025

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Status

Ongoing

Classification

Class II

Report Date

June 25, 2025

Termination Date

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Product Information

Product description
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Product quantity
4,608 bottles
Reason for recall
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
USA Nationwide.

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0471-2025
Event ID
96907
Recall initiation date
May 22, 2025
Center classification date
June 17, 2025
Code info
Lot#: AEF124004A, Exp date 08/31/2026
More code info
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