Recalls / Class III
Class IIID-0025-2019
Product
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
- Affected lot / code info
- Lot # 8508F004A; Exp. 02/20
Why it was recalled
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 5,790 cartons (526,890 tablets)
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2018-08-27
- FDA classified
- 2018-10-14
- Posted by FDA
- 2018-10-24
- Terminated
- 2019-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0025-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.