Why it was recalled
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Product description
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
Lot numbers, UPCs & expiration codes
Lot#: 20JUN010, Exp 5/12/21
Where it was sold
U.S.A. 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-0177-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2020
- FDA report date
- Jan 6, 2021
- Quantity
- 6520 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0177-2021, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87029
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot#: 20JUN010, Exp 5/12/21
- Postal code
- 07852-9720
- Report date
- Jan 6, 2021
- Product type
- Drugs
- Recall number
- D-0177-2021
- Classification
- Class II
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 6520 vials
- Termination date
- Aug 23, 2023
- Reason for recall
- Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Dec 17, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 30, 2020