Pain Reliever Tablet
FDA Recall NDC 0363-9947
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pain Reliever (NDC 0363-9947). A significant event, classified as Class II, was initiated on May 22, 2023 by Walgreen Co.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
May 22, 2023
May 31, 2023
87,360 bottles
Recall Profile & Regulatory Data
Event ID
92380
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
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.
Batch or Lot Expiration Information
Lot# Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
Affected Packages Involved in this Recall
0363-9947-29Product
0363-9947-35Product
0363-9947-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
