FDA-Drug2019-05-01Class II

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.

CMC Enterprise Pharmacy
Hazard

Lack of sterility assurance.

Sold states
NC
Affected count
6667 syringes
Manufactured in
4400 Golf Acres Dr, N/A, Charlotte, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1212-2019

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