Why it was recalled
Lack of Sterility Assurance.
Product description
Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
Lot numbers, UPCs & expiration codes
Lot #: 10081, BUD: 7/25/2017; 10096, BUD: 7/27/2017; 10112, BUD: 7/30/2017; 10117, BUD: 7/31/2017; 10152, BUD: 8/3/2017; 10159, BUD: 8/6/2017; 10170, BUD: 8/7/2017; 10174, BUD: 8/8/2017; 10193, BUD: 8/9/2017; 10202, BUD: 8/10/2017; 10212, BUD: 8/13/2017; 10242, BUD: 8/15/2017; 10276, BUD: 8/17/2017; 10294, BUD: 8/20/2017; 10320, BUD: 8/23/2017; 10328, BUD: 8/24/2017; 10334, BUD: 8/28/2017; 10342, BUD: 8/29/2017; 10364, BUD: 9/3/2017; 10392, BUD: 9/6/2017; 10420, BUD: 9/11/2017; 10427, BUD: 9/12/2017; 10440, BUD: 9/14/2017; 10463, BUD: 9/18/2017; 10495, BUD: 9/22/2017; 10499, BUD: 9/24/2017; 10512, BUD: 9/25/2017; 10556, BUD: 10/1/2017; 10567, BUD: 10/3/2017; 10583, BUD: 10/6/2017
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-1078-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 120856 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cantrell Drug Company
Original FDA data
Every field from FDA enforcement report D-1078-2017, 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 #: 10081, BUD: 7/25/2017; 10096, BUD: 7/27/2017; 10112, BUD: 7/30/2017; 10117, BUD: 7/31/2017; 10152, BUD: 8/3/2017; 10159, BUD: 8/6/2017; 10170, BUD: 8/7/2017; 10174, BUD: 8/8/2017; 10193, BUD: 8/9/2017; 10202, BUD: 8/10/2017; 10212, BUD: 8/13/2017; 10242, BUD: 8/15/2017; 10276, BUD: 8/17/2017; 10294, BUD: 8/20/2017; 10320, BUD: 8/23/2017; 10328, BUD: 8/24/2017; 10334, BUD: 8/28/2017; 10342, BUD: 8/29/2017; 10364, BUD: 9/3/2017; 10392, BUD: 9/6/2017; 10420, BUD: 9/11/2017; 10427, BUD: 9/12/2017; 10440, BUD: 9/14/2017; 10463, BUD: 9/18/2017; 10495, BUD: 9/22/2017; 10499, BUD: 9/24/2017; 10512, BUD: 9/25/2017; 10556, BUD: 10/1/2017; 10567, BUD: 10/3/2017; 10583, BUD: 10/6/2017
- Postal code
- 72207-4144
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1078-2017
- Classification
- Class II
- Recalling firm
- Cantrell Drug Company
- Product quantity
- 120856 syringes
- Termination date
- Sep 16, 2020
- Reason for recall
- Lack of Sterility Assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Jul 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2017