Why it was recalled
Defective Container; complaints of leakage.
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
Lot numbers, UPCs & expiration codes
Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
Where it was sold
Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0492-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 11, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 53,358 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Oxalis Labs
Original FDA data
Every field from FDA enforcement report D-0492-2019, exactly as published.
Show all FDA fields
- City
- Theda
- Status
- Terminated
- Country
- India
- Event ID
- 81914
- Address
- Lodhimajra
- Address (line 2)
- Tehsil - Baddi
- Code information
- Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0492-2019
- Classification
- Class III
- Recalling firm
- Oxalis Labs
- Product quantity
- 53,358 bottles
- Termination date
- Nov 6, 2019
- Reason for recall
- Defective Container; complaints of leakage.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.
- Recall initiation date
- Jan 11, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 14, 2019