FDA-Drug2019-05-01Class II

Alteplase 1 mg/mL 1 mL in 10 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
97 syringes
Manufactured in
4400 Golf Acres Dr, N/A, Charlotte, NC, United States
Products
Alteplase 1 mg/mL 1 mL in 10 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-1220-2019

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