PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white ro
Summary
The FDA issued a Class I for PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together w by CooperSurgical, Inc. Reason: Non-sterility.
Details
Source
Drug Recall
External ID
D-0643-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 517001,Exp 1/2024
Quantity Affected: 48,645 cartons
Reason for Recall
Non-sterility
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-04
Company
North Tonawanda, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
CooperSurgical, Inc has 38 FDA actions in our database, including 35 recalls and 3 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CooperSurgical, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperSurgical, Inc have FDA actions?
CooperSurgical, Inc has 38 FDA actions in our database, including 35 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0643-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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