Why it was recalled
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Product description
rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Lot numbers, UPCs & expiration codes
Lot# 36-262729, 36-262982, 36-262981, 36-262732, 36-262731, 36-262730, Exp 10/11/2023 ;
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-1113-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 17, 2023
- FDA report date
- Sep 6, 2023
- Quantity
- 3519 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-1113-2023, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 92898
- Address
- 2200 S 43rd Ave
- Code information
- Lot# 36-262729, 36-262982, 36-262981, 36-262732, 36-262731, 36-262730, Exp 10/11/2023 ;
- Postal code
- 85043-3909
- Report date
- Sep 6, 2023
- Product type
- Drugs
- Recall number
- D-1113-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 3519 Syringes
- Termination date
- Mar 27, 2025
- Reason for recall
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 28, 2023