Drug 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
D-383-2014
Product summary
- Event
- Event 66531
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,521 bottles
- Official record key
drug-enforcement:D-383-2014
Official wording
Reason: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Code information: Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin