FDA Drug Recalls

Recalls / Class II

Class IID-1390-2015

Product

Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Affected lot / code info
Lot #: 05142015@21, 05192015@22, 05282015@16, 06022015@18, 06102015@16, Exp 07/06/15

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
58 bags
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-1390-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls