FDA-Drug2022-02-23Class I

PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01

CooperSurgical, Inc
Hazard

Non-sterility

Sold states
US Nationwide
Affected count
48,645 cartons
Manufactured in
825 Wurlitzer Dr, N/A, North Tonawanda, NY, United States
Products
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0643-2022

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