Why it was recalled
Lack of Sterility Assurance.
Product description
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
Lot numbers, UPCs & expiration codes
Lot #: 9598, BUD: 8/2/2017; 9609, BUD: 8/5/2017; 9621, BUD: 8/7/2017; 9681, BUD: 8/19/2017; 9765, BUD: 9/5/2017; 10102, BUD: 10/24/2017; 10347, BUD: 11/26/2017; 10357, BUD: 11/26/2017; 10387, BUD: 12/3/2017; 10478, 10505, 10585, BUD: 12/16/2017
Where it was sold
Nationwide within the US
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-1079-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 28779 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cantrell Drug Company
Original FDA data
Every field from FDA enforcement report D-1079-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77780
- Address
- 7321 Cantrell Rd
- Code information
- Lot #: 9598, BUD: 8/2/2017; 9609, BUD: 8/5/2017; 9621, BUD: 8/7/2017; 9681, BUD: 8/19/2017; 9765, BUD: 9/5/2017; 10102, BUD: 10/24/2017; 10347, BUD: 11/26/2017; 10357, BUD: 11/26/2017; 10387, BUD: 12/3/2017; 10478, 10505, 10585, BUD: 12/16/2017
- Postal code
- 72207-4144
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1079-2017
- Classification
- Class II
- Recalling firm
- Cantrell Drug Company
- Product quantity
- 28779 syringes
- Termination date
- Sep 16, 2020
- Reason for recall
- Lack of Sterility Assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Jul 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2017