Why it was recalled
Lack of Assurance of Sterility.
Product description
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Lot numbers, UPCs & expiration codes
Lot #: 1219010961, Exp. 10/24/2019
Where it was sold
Nationwide in the U.S.
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-1843-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 16, 2019
- FDA report date
- Aug 28, 2019
- Quantity
- 922 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-1843-2019, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 83580
- Address
- 755 Rainbow Rd Ste B
- Code information
- Lot #: 1219010961, Exp. 10/24/2019
- Postal code
- 06095-1024
- Report date
- Aug 28, 2019
- Product type
- Drugs
- Recall number
- D-1843-2019
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product quantity
- 922 syringes
- Termination date
- Oct 15, 2019
- Reason for recall
- Lack of Assurance of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Aug 16, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2019