Recalls / Class II
Class IID-1065-2017
Product
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
- Affected lot / code info
- Lot #: 9783, BUD: 7/27/2017; 9801, BUD: 7/29/2017; 9807, BUD: 7/30/2017; 9847, BUD: 8/4/2017; 9954, BUD: 8/20/2017; 10022, BUD: 9/1/2017; 10052, BUD: 9/6/2017; 10063, BUD: 9/7/2017; 10086, BUD: 9/9/2017; 10108, BUD: 9/13/2017; 10156, BUD: 9/20/2017; 10180, BUD: 9/22/2017; 10245, BUD: 9/29/2017; 10264, BUD: 9/30/2017; 10322, BUD: 10/8/2017; 10339, BUD: 10/13/2017; 10368, BUD: 10/18/2017; 10406, BUD: 10/25/2017; 10419, BUD: 10/26/2017; 10435, BUD: 10/28/2017; 10455, BUD: 11/1/2017; 10489, BUD: 11/5/2017; 10497, BUD: 11/6/2017; 10516, BUD: 11/9/2017; 10527, BUD: 11/10/2017; 10577, BUD: 11/19/2017
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
- 75840 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-1065-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.