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Class II · ModerateRecall completed

Pain Reliever

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
Where it was soldThe recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byWALGREEN CO.
Brand namePAIN RELIEVER
Generic nameACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN
Distributed by / forWalgreen Co., 200 Wilmot Rd, Deerfield, IL 60015;
NDC0363-9947-35
Show the full FDA record
Full product labelPain 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.
Recalling firmAurobindo Pharma USA Inc.
DistributionThe recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
Quantity87,360 bottles
Recall initiated2023-05-22
Report date2023-05-31
Recall completed—
Recall numberD-0765-2023
ClassificationClass II
FDA statusCompleted
Origin on fileEast Windsor NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.