FDA Drug recall D-0627-2017
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc
- FDA Drug
- Class III
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class III recall of Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc by Alvogen, citing cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0627-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-07 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Alvogen |
| Distribution | US |
Product
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.
Reason
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Identifiers
| code_info | Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, Exp. 10/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0627-2017%22
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