Why it was recalled
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product description
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Lot numbers, UPCs & expiration codes
a) Lot # 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b) Lot # 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1220023315, BUD 2/1/2021; 1220023342, BUD 2/2/2021; 1220023431, BUD 2/4/2021; 1220023471, BUD 2/3/2021; 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021.
Where it was sold
Product was distributed to hospitals 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-0197-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2020
- FDA report date
- Jan 13, 2021
- Quantity
- 11,075 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0197-2021, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 86990
- Address
- 755 Rainbow Rd Ste B
- Code information
- a) Lot # 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b) Lot # 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1220023315, BUD 2/1/2021; 1220023342, BUD 2/2/2021; 1220023431, BUD 2/4/2021; 1220023471, BUD 2/3/2021; 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021.
- Postal code
- 06095-1024
- Report date
- Jan 13, 2021
- Product type
- Drugs
- Recall number
- D-0197-2021
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 11,075 syringes
- Termination date
- Nov 2, 2021
- Reason for recall
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
- Distribution pattern
- Product was distributed to hospitals nationwide.
- Recall initiation date
- Dec 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 7, 2021