Recalls / Class II
Class IID-1212-2019
Product
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Affected lot / code info
- Lots: EA241908 Exp. 4/24/2019; EB011905 Exp. 5/2/2019; EB081909 Exp. 5/9/2019; EB151910 Exp. 5/16/2019; EB251909 Exp. 5/26/2019; EC061907 Exp. 6/4/2019; EC151906 Exp. 6/13/2019
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- CMC Enterprise Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4400 Golf Acres Dr, N/A, Charlotte, North Carolina 28208-5968
Distribution
- Quantity
- 6667 syringes
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2019-04-12
- FDA classified
- 2019-04-23
- Posted by FDA
- 2019-05-01
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1212-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.