Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Norethindrone Acetate and Ethinyl Estradiol Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
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.
Affected NDCs
0378-7280-53
0378-7280-85
Compare with the code on your package — it is the most precise check available.
Drug: Estradiol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Norethindrone Acetate and Ethinyl Estradiol NDC 00378-7280 |
ETHINYL ESTRADIOL .02 mg/1; NORETHINDRONE ACETATE 1 mg/1 | Tablet Oral |
Mylan Pharmaceuticals Inc. | Rx |
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-7280-85
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0861-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Estradiol recalls
See all
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Other recalls by Mylan Pharmaceuticals Inc.
All 2017 recalls
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.