Sandoz Recalls Cefpodoxime Proxetil Tablets Due to Stainless Steel Particles
Sandoz, Inc. is recalling Cefpodoxime Proxetil tablets because they contain stainless steel particles. The recall covers 22,818 bottles distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of foreign stainless steel particles in an oral medication presents a risk of harm (such as injury to the gastrointestinal tract) even if specific injuries have not yet been reported in the source text.
Plain-English summary
Sandoz, Inc. is recalling Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. The recall is due to the presence of foreign substances, specifically stainless steel particles, in the product. The affected product is manufactured in Austria by Sandoz GmbH for Sandoz Inc. in Princeton, NJ, and carries NDC 0781-5439-20.
The recall involves 22,818 bottles distributed nationwide, including Puerto Rico. The specific lots affected are Lot # DZ4056 with an expiry date of 11/2015 and Lot # DZ4057 with an expiry date of 01/2016.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. This is a prescription-only medication, so patients should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- CEFPODOXIME PROXETIL (CEFPODOXIME PROXETIL)
- Brand
- CEFPODOXIME PROXETIL
- Manufacturer
- Sandoz, Inc
- Category
- Drug — Antibiotic
- Affected units
- 22,818
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 #: DZ4056
- Expiry: 11/2015
- Lot # DZ4057
- Expiry: 01/2016
Distribution
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