Recalls / Class II
Class IID-0817-2018
Product
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02
- Brand name
- Hydrocortisone
- Generic name
- Hydrocortisone
- Active ingredient
- Hydrocortisone
- Route
- Topical
- NDCs
- 45802-004, 45802-014
- FDA application
- ANDA085025
- Affected lot / code info
- Lot Numbers: 7AT0283V, exp. 11/18 7AT0284V, exp. 11/18 7AT0285V, exp. 11/18 7FT0460, exp. 05/19 7FT0461, exp. 05/19 7GT0465, exp. 06/19 7GT0466, exp. 06/19 7JT0390, exp. 08/19 7JT0392, exp. 08/19 7KT0588, exp. 09/19 7KT0589, exp. 09/19
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Perrigo New York
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1700 Bathgate Ave, Bronx, New York 10457-7512
Distribution
- Quantity
- 571,632 tubes
- Distribution pattern
- US Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2018-05-07
- FDA classified
- 2018-05-16
- Posted by FDA
- 2018-05-23
- Terminated
- 2018-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0817-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.