Why it was recalled
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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
Lot numbers, UPCs & expiration codes
Lot #: 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 15026752, 15026752, 15046752, 15066752, 15066753
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0392-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 27, 2015
- FDA report date
- Dec 9, 2015
- Quantity
- 844,704 suppositories
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Geritrex Corp
Original FDA data
Every field from FDA enforcement report D-0392-2016, exactly as published.
Show all FDA fields
- City
- Mount Vernon
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 72509
- Address
- 144 Kingsbridge Road East
- Code information
- Lot #: 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 15026752, 15026752, 15046752, 15066752, 15066753
- Postal code
- 10550
- Report date
- Dec 9, 2015
- Product type
- Drugs
- Recall number
- D-0392-2016
- Classification
- Class II
- Recalling firm
- Geritrex Corp
- Product quantity
- 844,704 suppositories
- Termination date
- Jun 11, 2018
- Reason for recall
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 27, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 27, 2015