Recalls / Class III
Class IIID-0629-2017
Product
Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05
- Affected lot / code info
- Lot #: BXH1BE1A, BXH1P41A, Exp. 01/2018.
Why it was recalled
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Recalling firm
- Firm
- Alvogen, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Bloomfield Ave Bldg B Ste 2, N/A, Pine Brook, New Jersey 07058-9743
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-07
- FDA classified
- 2017-04-04
- Posted by FDA
- 2017-04-12
- Terminated
- 2017-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0629-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.