Why it was recalled
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Product description
Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02
Lot numbers, UPCs & expiration codes
Lot #: 378440, Exp. 07/31/2023
Where it was sold
Nationwide in the U.S.
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-1170-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2022
- FDA report date
- Jul 6, 2022
- Quantity
- 2,736 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1170-2022, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 90442
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 378440, Exp. 07/31/2023
- Postal code
- 60045-4862
- Report date
- Jul 6, 2022
- Product type
- Drugs
- Recall number
- D-1170-2022
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 2,736 Bottles
- Termination date
- Sep 28, 2023
- Reason for recall
- Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jun 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2022