Qualitest Recalls Hydrocortisone Lotion for Excessive Potency
Qualitest Pharmaceuticals is recalling 109,620 bottles of Hydrocortisone Lotion, USP, 2.5% because the product is superpotent, meaning it contains more active ingredient than specified.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or manufacturing standards that is not likely to cause adverse health consequences.
Plain-English summary
Vintage Pharmaceuticals LLC, doing business as Qualitest Pharmaceuticals, is recalling 109,620 bottles of Hydrocortisone Lotion, USP, 2.5%, 2 FL OZ (59 mL). The product is a prescription-only medication manufactured for Qualitest Pharmaceuticals in Huntsville, Alabama, with NDC 0603-7785-52.
The recall was initiated because the product is superpotent, meaning it contains an amount of the active ingredient that is above the specified assay limits. The affected lots include 0000004961, 0000005197, 0000005198, 0000005199, 0000005201, 0000005202, 0000005203, 0000005204, 0000005200, 0000007998, 0000007999, 0000007022, 0000009176, 0000012281, and 0000012282, with expiration dates ranging from May 2017 to December 2018.
The product was distributed nationwide in the United States and Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been using this specific product.
The recalled product
- 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.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 109,620
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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