Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Tarceva (erlotinib)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Affected NDC
50242-0064-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Astellas Pharma US Inc
- NDC code
- 50242-064-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0008-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Astellas Pharma US Inc
All 2014 recalls
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk
Mycamine (micafungin)
Labeling: Label Error on Declared Strength
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Other dissolution failure recalls from 2014
All dissolution failure recalls
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Class II · Moderate risk
Mercaptopurine Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 12 month stability time point
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specification; at the 6-month stability time point
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