FDAClass IIIMay 31, 2017

Hydrocortisone recall: Superpotent

HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC…

Why was Hydrocortisone recalled?

Superpotent Drug: above specification for the assay.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC…
Recalling firm
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Quantity
109,620 bottles
Distribution
Nationwide in the USA and Puerto Rico.
Recall date
May 31, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls