Pain Reliever recall: Impurity Out of Spec
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.
Why was Pain Reliever recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
- Product
- 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.
- Recalling firm
- Aurobindo Pharma USA Inc.
- Quantity
- 87,360 bottles
- Distribution
- The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)