Recalls / Class III
Class IIID-0859-2017
Product
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
- Affected lot / code info
- Lot #: 0000004961, Exp. 05/17; 0000005197, 0000005198, 0000005199, Exp. 07/17; 0000005201, 0000005202, 0000005203, 0000005204, Exp. 09/17; 0000005200, 0000007998, 0000007999, 0000007022, Exp. 12/17; 0000009176, Exp. 04/18; 0000012281, 0000012282, Exp. 12/18
Why it was recalled
Superpotent Drug: above specification for the assay.
Recalling firm
- Firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Vintage Dr NE, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 109,620 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2017-05-08
- FDA classified
- 2017-05-23
- Posted by FDA
- 2017-05-31
- Terminated
- 2018-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0859-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.