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
Reported: January 1, 2014 Initiated: October 22, 2013 #D-383-2014
Product Description
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
Details
- Recalling Firm
- Sandoz Incorporated
- Units Affected
- 12,521 bottles
- Distribution
- Nationwide
- Location
- Broomfield, CO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Incorporated. Units affected: 12,521 bottles.
Why was this product recalled? ▼
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 1, 2014. Severity: Moderate. Recall number: D-383-2014.
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