Reported Feb 20, 2019 · Terminated
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc.…
Oxalis Labs
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oxalis Labs · Lodhimajra · Theda, N/A · N/A
Is this the product you have?
Clobetasol Propionate Topical Solution USP0.05% w/w50 mL bottle
- Manufactured forMacleods Pharma USA, Inc. Plainsboro
- NJ 08536 ManufacturerMacleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86
- Lot codes and dates
- Lot Numbers
PCA801APCA802APCA803Aexp. date 12/2019PCA804APCA805APCA806APCA807Aexp. date 04/2020
- Lot Numbers
- Amount recalled
- 53,358 bottles
Where it was sold
Why it was recalled
Defective Container; complaints of leakage.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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