Why it was recalled
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Product description
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
Lot numbers, UPCs & expiration codes
Lot #: 101456, Exp 05/13; 101488, Exp 06/13: 101499, 101503, Exp 07/13; 101537, 101552, 101554, Exp 08/13; 101611, 101616, 101623, Exp 10/13; 101630, Exp 11/13; 101754, Exp 03/14
Where it was sold
Nationwide and Puerto Rico
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-250-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2013
- FDA report date
- Apr 24, 2013
- Quantity
- 9,268 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Precision Dose Inc.
Original FDA data
Every field from FDA enforcement report D-250-2013, exactly as published.
Show all FDA fields
- City
- South Beloit
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64676
- Address
- 722 Progressive Ln
- Code information
- Lot #: 101456, Exp 05/13; 101488, Exp 06/13: 101499, 101503, Exp 07/13; 101537, 101552, 101554, Exp 08/13; 101611, 101616, 101623, Exp 10/13; 101630, Exp 11/13; 101754, Exp 03/14
- Postal code
- 61080-2616
- Report date
- Apr 24, 2013
- Product type
- Drugs
- Recall number
- D-250-2013
- Classification
- Class II
- Recalling firm
- Precision Dose Inc.
- Product quantity
- 9,268 cases
- Termination date
- May 7, 2015
- Reason for recall
- Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 21, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 15, 2013