Recalls / Class II
Class IID-0191-2017
Product
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15
- Affected lot / code info
- Lot: 9006 BUD: 1/20/2017, Lot: 8757 BUD: 11/30/2016, Lot: 8954 BUD: 1/6/2017, Lot: 9174 BUD: 2/20/2017
Why it was recalled
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Recalling firm
- Firm
- Cantrell Drug Company
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 7321 Cantrell Rd, Little Rock, Arkansas 72207-4144
Distribution
- Quantity
- 48,592 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-18
- FDA classified
- 2016-12-13
- Posted by FDA
- 2016-12-21
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0191-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.