CLASS II Drug recall · Reported 4 Jun 2014 · FDA Enforcement Report
ParaGard T 380A - Intrauterine Copper Contraceptive recalled
Teva Pharmaceuticals USA is recalling ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed, distributed in Kentucky, New York. The recall was initiated on 21 Mar 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1354-2014
- FDA event ID
- 67809
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Mar 2014
- FDA classified
- 28 May 2014
- Reported
- 4 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Hormones & Birth Control
Timeline
| 21 Mar 2014 | Recall initiated by company | |
| 28 May 2014 | Classified by FDA | +68 days |
| 4 Jun 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterility: due to a failed sterility test
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Where it was distributed
NY and KY
Questions about this recall
Why was it recalled?
Non-sterility: due to a failed sterility test
Which lots are affected?
508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units
Where was it sold?
NY and KY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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