Why it was recalled
Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.
Product description
ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
Lot numbers, UPCs & expiration codes
Lot #: 13A026, Exp 01/15
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-919-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 17, 2013
- FDA report date
- Sep 4, 2013
- Quantity
- 16,440 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advance Pharmaceutical Inc
Original FDA data
Every field from FDA enforcement report D-919-2013, exactly as published.
Show all FDA fields
- City
- Holtsville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65484
- Address
- 895 Waverly Avenue
- Code information
- Lot #: 13A026, Exp 01/15
- Postal code
- 11742
- Report date
- Sep 4, 2013
- Product type
- Drugs
- Recall number
- D-919-2013
- Classification
- Class I
- Recalling firm
- Advance Pharmaceutical Inc
- Product quantity
- 16,440 bottles
- Termination date
- May 19, 2016
- Reason for recall
- Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 17, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 23, 2013