FDA-Drug2015-11-25Class II

HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Downing Labs, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Affected count
1062 vials
Manufactured in
4001 McEwen Rd Suite 110, N/A, Dallas, TX, United States
Products
HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0355-2016

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