Recalls / Class II
Class IID-383-2014
Product
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
- Brand name
- Tacrolimus
- Generic name
- Tacrolimus
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 0781-2102, 0781-2103, 0781-2104
- FDA application
- ANDA065461
- Affected lot / code info
- Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Why it was recalled
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Recalling firm
- Firm
- Sandoz Incorporated
- Manufacturer
- Sandoz Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 12,521 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-22
- FDA classified
- 2013-12-20
- Posted by FDA
- 2014-01-01
- Terminated
- 2014-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-383-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.