Perrigo Recalls Salicylic Acid Cream Due to Organic Impurity
L. Perrigo Company is recalling Salicylic Acid Cream, 6%, due to an out-of-specification organic impurity. The FDA classified this as a Class III recall.
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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
L. Perrigo Company is voluntarily recalling Salicylic Acid Cream, 6%, 400g bottle, Rx Only. The recall involves specific lots of the product manufactured by Perrigo Yeruham, Israel, and distributed by Perrigo Allegan, MI. The total quantity affected is 10,656 units.
The recall was initiated because the active pharmaceutical ingredient (API) for these products had an out-of-specification result for an organic impurity. The affected products are identified by Lot # 098840 and 098779, with an expiration date of 06/18. The products were distributed nationwide within the United States.
The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- Product
- Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
- Manufacturer
- L. Perrigo Company
- Category
- Drug — Topical Prescription
- Hazard
- Affected units
- 10,656
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 (3)
- Lot #: 098840
- 098779
- Exp.06/18.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by L. Perrigo Company under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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