Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Salicylic Acid Cream
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
45802-0806-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- L. Perrigo Company
- NDC code
- 45802-806-01
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0504-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by L. Perrigo Company
All 2017 recalls
Class II · Moderate risk
Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergyrelief
Failed Impurities/Degradation Specifications
Other impurity / degradation recalls from 2017
All impurity / degradation recalls
Class II · Moderate risk
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class III · Low risk
Penicillin V Potassium for Oral Solution
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class III · Low risk
Isradapine Capsules USP 2.5 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.