Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walg
Summary
The FDA issued a Class II for Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in by Aurobindo Pharma USA Inc.. Reason: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of spec.
Details
Source
Drug Recall
External ID
D-0765-2023
Action Date
2023-05-31
Status
Completed
Category
drug
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.
Lot/Code Info: Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
Quantity Affected: 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.
Distribution
The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-22
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 216 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aurobindo Pharma USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurobindo Pharma USA Inc. have FDA actions?
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0765-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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