The Recall Desk
ModerateFDA (Drugs)·D-0970-2015·Announced 2015-05-06

Teva Recalls Fluoxetine Capsules Due to Residual Solvent Impurity

Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules 10 mg due to an elevated level of a residual solvent impurity in the active ingredient.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves a chemical impurity exceeding toxicological thresholds, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported immediate serious injury.

Plain-English summary

Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 10 mg, in 100-count bottles. The affected product is prescription-only and was manufactured by Pliva Krakow Pharmaceutical Company S.A. in Krakow, Poland, for Teva Pharmaceuticals USA in Sellersville, PA. The specific lot number is 6A207012, with an expiration date of 7/2015. The product was distributed nationwide.

The recall was initiated because the product contains an elevated level of a residual solvent impurity in the active pharmaceutical ingredient (API). This level exceeds the Threshold of Toxicological Concern (TTC) calculation for the 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.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be discontinued and returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
FLUOXETINE (FLUOXETINE)
Brand
FLUOXETINE
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard

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 (2)

  • Lot #: 6A207012
  • Exp 7/2015.

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.

See all 2 products in this recall →

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