Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Reported: September 2, 2015 Initiated: June 15, 2015 #D-1384-2015
Product Description
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Reason for Recall
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.
Details
- Recalling Firm
- Liberty Drug & Surgical
- Units Affected
- 2 vials
- Distribution
- Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
- Location
- Chatham, NJ
Frequently Asked Questions
What product was recalled? ▼
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.. Recalled by Liberty Drug & Surgical. Units affected: 2 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2015. Severity: Moderate. Recall number: D-1384-2015.
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