Teva Recalls Fluoxetine Capsules Due to Residual Solvent Impurity
Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules USP, 20 mg, due to an elevated level of a residual solvent impurity in the active pharmaceutical ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving chemical contamination that exceeds toxicological thresholds, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 20 mg, in 500-count and 1000-count bottles. The affected products are prescription-only and were manufactured by Pliva Krakow Pharmaceutical Company S.A. in Krakow, Poland, for Teva Pharmaceuticals USA in Sellersville, PA. The recall covers Lot # 6A208123 (NDC 50111-648-02) and Lot # 6A208121 (NDC 50111-648-03), both with an expiration date of 8/2015.
The recall was initiated because the product contains an elevated level of a residual solvent impurity in the active pharmaceutical ingredient (API) that exceeds the Threshold of Toxicological Concern (TTC) calculation for that impurity. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected products were distributed nationwide. Patients and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatment options. Consumers should not return the medication to the pharmacy unless instructed to do so by a healthcare professional.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: a) 6A208123
- Exp 8/2015
- b) 6A208121
- Exp 8/2015.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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