Sandoz Recalls Subpotent Amoxicillin and Clavulanate Potassium Tablets
Sandoz Inc is recalling 4,464 bottles of Amoxicillin and Clavulanate Potassium tablets found to be subpotent in clavulanic acid.
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 FDA classified this recall as Class III, which by definition indicates that use of the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Sandoz Inc is recalling 4,464 bottles of Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg. The recall is due to the product being subpotent in clavulanic acid. The affected product is Lot FP8735, manufactured in August 2017, and distributed in New York and Ohio.
The product is a prescription-only medication manufactured in Austria by Sandoz GmbH for Sandoz Inc. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for a replacement or alternative treatment. The recall number is D-0868-2017.
The recalled product
- Product
- AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
- Brand
- AMOXICILLIN AND CLAVULANATE POTASSIUM
- Manufacturer
- Sandoz Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 4,464
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 FP8735
- 8/2017
UPCs (4)
- 0307816102462
- 0307811831206
- 0307811874319
- 0307811852201
Distribution
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