Why it was recalled
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Product description
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Lot numbers, UPCs & expiration codes
Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17-272051, Exp. 8/9/2023; 17-272227, Exp. 8/13/2023; 17-272343, Exp. 8/15/2023; 17-272799, Exp. 8/22/2023; 17-273173, Exp. 8/29/2023; 17-273495, Exp. 9/4/2023.
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-1054-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 2,082 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services Inc
Original FDA data
Every field from FDA enforcement report D-1054-2023, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 92752
- Address
- 7935 Dunbrook Rd Ste C
- Code information
- Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17-272051, Exp. 8/9/2023; 17-272227, Exp. 8/13/2023; 17-272343, Exp. 8/15/2023; 17-272799, Exp. 8/22/2023; 17-273173, Exp. 8/29/2023; 17-273495, Exp. 9/4/2023.
- Postal code
- 92126-6322
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-1054-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services Inc
- Product quantity
- 2,082 syringes
- Termination date
- Mar 21, 2025
- Reason for recall
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2023