FDA Drug recall D-0861-2017
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged i…
- FDA Drug
- Class III
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class III recall of Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged i… by Mylan Pharmaceuticals, citing 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 repai….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0861-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-01-30 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
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.
Reason
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.
Identifiers
| ndc | 0378-7280-85 |
|---|---|
| ndc | 0378-7280-53 |
| code_info | Lot #: 6327A006, Exp 02/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Mylan Pharmaceuticals
- Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made…
FDA Drug · Class II · 2026-09-09 · Mylan Pharmaceuticals - Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institu…
FDA Drug · Class II · 2026-09-09 · Mylan Pharmaceuticals - Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pha…
FDA Drug · Class II · 2026-08-26 · Mylan Pharmaceuticals - Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional…
FDA Drug · Class II · 2026-08-05 · Mylan Pharmaceuticals - Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals…
FDA Drug · Class II · 2026-03-11 · Mylan Pharmaceuticals
All Mylan Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0861-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.