Recalls / Class III
Class IIID-0861-2017
Product
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.
- Brand name
- Norethindrone Acetate And Ethinyl Estradiol
- Generic name
- Norethindrone Acetate And Ethinyl Estradiol
- Active ingredients
- Ethinyl Estradiol, Norethindrone Acetate
- Route
- Oral
- NDC
- 0378-7280
- FDA application
- ANDA202771
- Affected lot / code info
- Lot #: 6327A006, Exp 02/18
Why it was recalled
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 8,605 cartons
- Distribution pattern
- Nationwide in USA
Timeline
- Recall initiated
- 2017-01-30
- FDA classified
- 2017-05-23
- Posted by FDA
- 2017-05-31
- Terminated
- 2017-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0861-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.