Recalls / Class II
Class IID-1066-2017
Product
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
- Affected lot / code info
- Lot #: 9781, BUD: 7/26/2017; 9784, BUD: 7/27/2017; 9822, BUD: 8/2/2017; 9852, BUD: 8/5/2017; 10061, BUD: 9/7/2017; 10105, BUD: 9/13/2017; 10150, BUD: 9/17/2017; 10178, BUD: 9/22/2017; 10185, BUD: 9/23/2017; 10501, BUD: 11/8/2017
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
- 21080 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-1066-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.