Class II
Terminated
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
This recall has been terminated (originally issued October 15, 2014).
- Company
- Astellas Pharma Us Inc
- Recall Initiated
- September 15, 2014
- Posted
- October 15, 2014
- Recall Number
- D-0008-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,236 bottles
- Firm Location
- Northbrook, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Distribution
Nationwide
Lot / Code Info
Lot 66482CW, Exp 04/16
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