FDAClass IIJune 4, 2014

ParaGard T 380A - Intrauterine Copper Contraceptive recall: Sterility Concern

ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc.…

Why was ParaGard T 380A - Intrauterine Copper Contraceptive recalled?

Non-sterility: due to a failed sterility test

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units

Product
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc.…
Recalling firm
Teva Pharmaceuticals USA
Quantity
47890
Distribution
NY and KY
Recall date
June 4, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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