Why it was recalled
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Product description
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
Lot numbers, UPCs & expiration codes
Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
Where it was sold
USA Nationwide
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-0802-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2021
- FDA report date
- Sep 22, 2021
- Quantity
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0802-2021, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 88488
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: a) 372286, 372289, Exp 1/31/2022, b) 372286, 372289, Exp 1/31/2022
- Postal code
- 60045-4862
- Report date
- Sep 22, 2021
- Product type
- Drugs
- Recall number
- D-0802-2021
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289
- Termination date
- Aug 17, 2022
- Reason for recall
- Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 13, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2021