Recalls / Class II
Class IID-1395-2015
Product
Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
- Affected lot / code info
- Lot #: 05012015@1, Exp 06/15/15; 06022015@14, Exp 07/17/15; 06112015@10, Exp 07/26/15
Why it was recalled
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recalling firm
- Firm
- Liberty Drug & Surgical
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 195 Main St, N/A, Chatham, New Jersey 07928-2405
Distribution
- Quantity
- 22 vials
- Distribution pattern
- Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Timeline
- Recall initiated
- 2015-06-15
- FDA classified
- 2015-08-27
- Posted by FDA
- 2015-09-02
- Terminated
- 2018-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1395-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.