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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Prescription Medication
- Hazard
- 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:
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