Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86
Reported: February 20, 2019 Initiated: January 11, 2019 #D-0492-2019
Product Description
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86
Reason for Recall
Defective Container; complaints of leakage.
Details
- Recalling Firm
- Oxalis Labs
- Units Affected
- 53,358 bottles
- Distribution
- Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.
- Location
- Theda, N/A
Frequently Asked Questions
What product was recalled? ▼
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86. Recalled by Oxalis Labs. Units affected: 53,358 bottles.
Why was this product recalled? ▼
Defective Container; complaints of leakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2019. Severity: Low. Recall number: D-0492-2019.
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