Why it was recalled
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Product description
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
Lot numbers, UPCs & expiration codes
lot # 45810; Exp. 05/18
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0663-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 25, 2015
- FDA report date
- Feb 24, 2016
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medline Industries Inc
Original FDA data
Every field from FDA enforcement report D-0663-2016, exactly as published.
Show all FDA fields
- City
- Mundelein
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72323
- Address
- 1 Medline Pl
- Code information
- lot # 45810; Exp. 05/18
- Postal code
- 60060-4485
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0663-2016
- Classification
- Class I
- Recalling firm
- Medline Industries Inc
- Termination date
- Jun 29, 2016
- Reason for recall
- Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 25, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 12, 2016