Why it was recalled
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Product description
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Lot numbers, UPCs & expiration codes
Lot #: 500326, Exp. 6/30/2018
Where it was sold
OH and CT
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-1037-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 5, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 480 (5mL) unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Precision Dose Inc.
Original FDA data
Every field from FDA enforcement report D-1037-2017, exactly as published.
Show all FDA fields
- City
- South Beloit
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77732
- Address
- 722 Progressive Ln
- Code information
- Lot #: 500326, Exp. 6/30/2018
- Postal code
- 61080-2616
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1037-2017
- Classification
- Class II
- Recalling firm
- Precision Dose Inc.
- Product quantity
- 480 (5mL) unit dose cups
- Termination date
- Mar 28, 2018
- Reason for recall
- Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
- Distribution pattern
- OH and CT
- Recall initiation date
- Jul 5, 2017
- Initial firm notification
- Telephone
- Center classification date
- Jul 31, 2017