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

FDA recall notice · announced June 4, 2014 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Non-sterility: due to a failed sterility test

Notes

Distribution: NY and KY
Lot/code information: 508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units
Quantity: 47890
Status: Terminated
Products in this recall event:
- ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY (D-1354-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.