Perrigo Recalls Salicylic Acid Shampoo Due to Organic Impurity
L. Perrigo Company is recalling Salicylic Acid Shampoo, 6%, because the active ingredient failed impurity specifications.
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 recall as Class III, 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 recalling Salicylic Acid Shampoo, 6%, 177 mL bottles. The recall involves 10,656 units distributed nationwide within the United States. The specific lots affected are 099534 (expiration 07/18) and 099512 (expiration 06/18).
The recall was initiated because the active pharmaceutical ingredient (API) for these products had an out-of-specification result for an organic impurity. 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 with this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The product is prescription-only, so patients should consult their prescriber regarding replacement or alternative treatments.
The recalled product
- Product
- Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.
- Manufacturer
- L. Perrigo Company
- Category
- Drug — Topical Dermatological
- 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 #: 099534
- Exp. 07/18
- 099512 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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