GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12
Reported: December 9, 2015 Initiated: October 27, 2015 #D-0392-2016
Product Description
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12
Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Details
- Recalling Firm
- Geritrex Corp
- Units Affected
- 844,704 suppositories
- Distribution
- Nationwide
- Location
- Mount Vernon, NY
Frequently Asked Questions
What product was recalled? ▼
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12. Recalled by Geritrex Corp. Units affected: 844,704 suppositories.
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2015. Severity: Moderate. Recall number: D-0392-2016.
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