CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
Reported: March 1, 2017 Initiated: February 3, 2017 #D-0475-2017
Product Description
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
Reason for Recall
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 19,584 bottles
- Distribution
- Distributed Nationwide
- Location
- North York, N/A
Frequently Asked Questions
What product was recalled? ▼
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0. Recalled by Apotex Inc.. Units affected: 19,584 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 1, 2017. Severity: Moderate. Recall number: D-0475-2017.
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