Why it was recalled
Superpotent Drug: above specification for the assay.
Product description
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0859-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 8, 2017
- FDA report date
- May 31, 2017
- Quantity
- 109,620 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0859-2017, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 77210
- Address
- 150 Vintage Dr NE
- Code information
- 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
- Postal code
- 35811-8216
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0859-2017
- Classification
- Class III
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Product quantity
- 109,620 bottles
- Termination date
- May 2, 2018
- Reason for recall
- Superpotent Drug: above specification for the assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- May 8, 2017
- Initial firm notification
- Letter
- Center classification date
- May 23, 2017