Why it was recalled
Lack of assurance of sterility:
Product description
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Lot numbers, UPCs & expiration codes
Lot: 17-275231, 17-275232, Exp. 10/2/2023; 17-275563, 17-275567, 17-275573, 17-275580, Exp. 10/8/2023; 17-275767, 17-275784, Exp. 10/10/2023;
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-0005-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2023
- FDA report date
- Oct 11, 2023
- Quantity
- 3,384 10 mL syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services Inc
Original FDA data
Every field from FDA enforcement report D-0005-2024, 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: 17-275231, 17-275232, Exp. 10/2/2023; 17-275563, 17-275567, 17-275573, 17-275580, Exp. 10/8/2023; 17-275767, 17-275784, Exp. 10/10/2023;
- Postal code
- 92126-6322
- Report date
- Oct 11, 2023
- Product type
- Drugs
- Recall number
- D-0005-2024
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services Inc
- Product quantity
- 3,384 10 mL syringes
- Termination date
- Mar 19, 2025
- Reason for recall
- Lack of assurance of sterility:
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 21, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 4, 2023