FDA Drug recall D-383-2014
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ…
- FDA Drug
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ… by Sandoz, citing cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-383-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-22 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Identifiers
| ndc | 0781-2102-01 |
|---|---|
| ndc | 0781-2103-01 |
| ndc | 0781-2104-01 |
| code_info | Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-383-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.