Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Fluoxetine Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
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
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.
Affected NDC
68645-0130-54
Compare with the code on your package — it is the most precise check available.
Drug: Fluoxetine Category: Mental Health Medication
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 |
|---|---|---|---|---|
| Fluoxetine NDC 68645-0130 |
HYDROCHLORIDE 20 mg/1 | Capsule Oral |
Legacy Pharmaceutical Packaging, LLC | Rx |
- Recalling firm
- Legacy Pharmaceutical Packaging
- NDC code
- 68645-130-54
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1279-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluoxetine recalls
See all
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class III · Low risk
Fluoxetine Tablets USP
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Other recalls by Legacy Pharmaceutical Packaging
All 2014 recalls
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class III · Low risk
Metformin Hydrochloride Tablets USP
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
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