Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure
Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated Severe (4). While specific injury reports are not detailed in the text, the Class II classification for a medical device involving sterility failure meets the threshold for Severe.
Plain-English summary
Teva Pharmaceuticals USA is recalling 47,890 units of ParaGard T 380A Intrauterine Copper Contraceptive. The recall affects single units and cartons of five units with NDC 51285-204-01 and NDC 51285-204-02, expiration date 4/2015, and code 508004. The product was distributed in New York and Kentucky.
The recall was initiated because the product failed a sterility test. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased or received this product should contact their healthcare provider for guidance on removal or replacement. The recalling firm is Teva Pharmaceuticals USA.
The recalled product
- Product
- ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 47,890
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 508004
- exp. 4/2015
- NDC 51285-204-01
- Single Unit 508004
- NDC 51285-204-02
- Carton of 5 Units
Distribution
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