Recalls / Class II
Class IID-1078-2017
Product
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Sterility Assurance.
Recalling firm
- Firm
- Cantrell Drug Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7321 Cantrell Rd, N/A, Little Rock, Arkansas 72207-4144
Distribution
- Quantity
- 120856 syringes
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-07-14
- FDA classified
- 2017-08-09
- Posted by FDA
- 2017-08-16
- Terminated
- 2020-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1078-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.