Astellas Recalls Tarceva Tablets Due to Failed Dissolution Specifications
Astellas Pharma US Inc is recalling 9,236 bottles of Tarceva (erlotinib) 150 mg tablets because they failed routine stability testing for dissolution.
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 recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute injury risk.
Plain-English summary
Astellas Pharma US Inc is recalling 9,236 bottles of Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only. The product was manufactured by Kremers Urban Pharmaceuticals Inc. in Seymour, IN, and carries NDC 50242-064-01. The specific lot affected is 66482CW with an expiration date of 04/16.
The recall was initiated because the product did not meet the acceptance criteria for the dissolution test during 24-month routine stability testing. This indicates that the tablets may not dissolve at the required rate, which could affect the delivery of the medication.
The affected product was distributed nationwide. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or the recalling firm for disposal or replacement.
The recalled product
- Product
- Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
- Manufacturer
- Astellas Pharma US Inc
- Category
- Drug — Oncology
- Hazard
- Affected units
- 9,236
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 66482CW
- Exp 04/16
Distribution
Distributed nationwide across the United States.
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