Recalls / Class II
Class IID-1070-2017
Product
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
- Affected lot / code info
- Lot #: 10095, BUD: 7/27/2017; 10119, BUD: 7/31/2017; 10135, BUD: 8/2/2017; 10162, BUD: 8/6/2017; 10168, BUD: 8/7/2017; 10186, BUD: 8/9/2017; 10247, BUD: 8/15/2017; 10301, BUD: 8/21/2017; 10325, BUD: 8/24/2017; 10390, BUD: 9/5/2017; 10465, BUD: 9/18/2017; 10487, BUD: 9/20/2017; 10542, BUD: 9/27/2017
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
- 8928 bags
- 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-1070-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.