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.
Nortrel 7/7/7 (Norethindrone and Ethinyl Estradiol)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
Affected NDC
0555-9012-58
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 |
|---|---|---|---|---|
| Nortrel 7/7/7 (28 Day Regimen) Norethindrone and Ethinyl Estradiol NDC 00555-9012 |
Kit | Teva Pharmaceuticals USA, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- NDC code
- 0555-9012-58
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0322-2024 · 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.
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Class II · Moderate risk
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traZODone Hydrochloride Tablets
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