PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 23, 2022 Initiated: February 4, 2022 #D-0643-2022

Product Description

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

Reason for Recall

Non-sterility

Details

Recalling Firm
CooperSurgical, Inc
Units Affected
48,645 cartons
Distribution
US Nationwide
Location
North Tonawanda, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by CooperSurgical, Inc. Units affected: 48,645 cartons.
Why was this product recalled?
Non-sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on February 23, 2022. Severity: Critical. Recall number: D-0643-2022.