Geritrex Recalls Unapproved Hydrocortisone Suppositories Nationwide
Geritrex Corp is recalling GRx HiCort 25 suppositories because the FDA determined they are unapproved new drugs and misbranded.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is FDA Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Geritrex Corp is recalling GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only. The product is distributed by Geritrex Corporation in Mount Vernon, NY, and carries NDC 54162-015-12. The recall covers 844,704 suppositories distributed nationwide.
The FDA has determined that the products are unapproved new drugs and misbranded because they were marketed without an Approved NDA/ANDA. This classification indicates that the drugs have not received FDA approval for their intended use.
Consumers and healthcare providers should stop using the affected suppositories and contact their healthcare provider for further instructions. The recall is classified as FDA Class II, which means use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- Geritrex Corp
- Category
- Drug — Suppositories
- Affected units
- 844,704
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: 1310001
- 13J04
- 1310167
- 1311013
- 1312008
- 1401055
- 13S02
- 14A05
- 1402061
- 14C01
- 14C05
- 14C06
- 14E02
- 1405081
- 1406107
- 1407062
- 14096751
- 14096752
- 14096753
- 15026752
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Geritrex Corp under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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