Why it was recalled
Lack of assurance of sterility:
Product description
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
Lot numbers, UPCs & expiration codes
Lot: 17-275224, 17-275225, 17-275233, 17-275235, 17-275253, 17-275259, 17-275263, 17-275267 Exp. 10/2/2023; 17-275340, Exp. 10/3/2023; 17-275512, Exp. 10/5/2023; 17-275633, 17-275657, Exp. 10/8/2023.
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-0002-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2023
- FDA report date
- Oct 11, 2023
- Quantity
- 4,775 5 mL Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services Inc
Original FDA data
Every field from FDA enforcement report D-0002-2024, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 93103
- Address
- 7935 Dunbrook Rd Ste C
- Code information
- Lot: 17-275224, 17-275225, 17-275233, 17-275235, 17-275253, 17-275259, 17-275263, 17-275267 Exp. 10/2/2023; 17-275340, Exp. 10/3/2023; 17-275512, Exp. 10/5/2023; 17-275633, 17-275657, Exp. 10/8/2023.
- Postal code
- 92126-6322
- Report date
- Oct 11, 2023
- Product type
- Drugs
- Recall number
- D-0002-2024
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services Inc
- Product quantity
- 4,775 5 mL Syringes
- Termination date
- Mar 19, 2025
- Reason for recall
- Lack of assurance of sterility:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 21, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 4, 2023