Perrigo Recalls Subpotent Mometasone Furoate Ointment Tubes Nationwide
Perrigo Israel Pharmaceuticals is voluntarily recalling 158,268 tubes of Mometasone Furoate Ointment USP, 0.1%, because the product is subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Perrigo Israel Pharmaceuticals is voluntarily recalling 158,268 tubes of Mometasone Furoate Ointment USP, 0.1%, 15 g tubes. The product is prescription-only and was manufactured in Israel and distributed in Allegan, Michigan. The recall was initiated on July 13, 2015, and terminated on February 11, 2016.
The reason for the recall is that the drug is subpotent, meaning it contains less of the active ingredient than labeled. The affected lots are 063630 (Exp 04/16), 069793 (Exp 11/16), 071745 (Exp 02/17), 076150 (Exp 07/17), and 081317 (Exp 12/17). The product was distributed nationwide and in Puerto Rico.
The FDA classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers listed and return the product to the distributor or follow instructions from their healthcare provider.
The recalled product
- Product
- Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37
- Manufacturer
- Perrigo Israel Pharmaceuticals
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 158,268
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 (10)
- Lot # 063630
- Exp 04/16
- 069793
- Exp 11/16
- 071745
- Exp 02/17
- 076150
- Exp 07/17
- 081317
- Exp 12/17
Distribution
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