Recalls / Class II
Class IID-0177-2021
Product
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
- Affected lot / code info
- Lot#: 20JUN010, Exp 5/12/21
Why it was recalled
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, N/A, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 6520 vials
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2020-12-30
- Posted by FDA
- 2021-01-06
- Terminated
- 2023-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0177-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.