Why it was recalled
Subpotent Drug: low out of specification results.
Product description
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Lot numbers, UPCs & expiration codes
Lot number: 500105, Exp 04/30/18
Where it was sold
Nationwide in the USA
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-0057-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 25, 2017
- FDA report date
- Nov 8, 2017
- Quantity
- 801 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Precision Dose Inc.
Original FDA data
Every field from FDA enforcement report D-0057-2018, exactly as published.
Show all FDA fields
- City
- South Beloit
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78359
- Address
- 722 Progressive Ln
- Code information
- Lot number: 500105, Exp 04/30/18
- Postal code
- 61080-2616
- Report date
- Nov 8, 2017
- Product type
- Drugs
- Recall number
- D-0057-2018
- Classification
- Class III
- Recalling firm
- Precision Dose Inc.
- Product quantity
- 801 cases
- Termination date
- Apr 23, 2018
- Reason for recall
- Subpotent Drug: low out of specification results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 25, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2017