The Recall Desk
LowFDA (Drugs)·D-0291-2015·Announced 2014-12-17

Sandoz Recalls Fluoxetine Capsules Due to Illegible Logo

Sandoz Inc. is recalling one lot of Fluoxetine Capsules because the logo on the capsules is illegible.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III and involves a cosmetic labeling defect (illegible logo) with no reported health hazards or injuries.

Plain-English summary

Sandoz Inc. is recalling one lot of Fluoxetine Capsules USP, 20 mg, 100 count bottles. The recall is due to an illegible logo on the capsules.

The affected product is identified by Lot ET5122 with an expiration date of 10/17. The NDC number is 0781-2822-01. A total of 1,008 bottles were distributed to Arizona.

Consumers with this specific lot should contact their pharmacist or healthcare provider for guidance on returning the product or obtaining a replacement.

The recalled product

Product
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Affected units
1,008

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 ET5122
  • Exp. 10/17

Distribution

Distributed in 1 state: