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

FDA recall notice · announced January 1, 2014 · Sandoz

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Notes

Distribution: Nationwide
Lot/code information: Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Quantity: 12,521 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.