Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Reported: August 22, 2018 Initiated: July 25, 2018 #D-1094-2018
Product Description
Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Details
- Recalling Firm
- Ranier's Compounding Laboratory
- Units Affected
- 2 vials
- Distribution
- Product was distributed within the state of Pennsylvania.
- Location
- Jeannette, PA
Frequently Asked Questions
What product was recalled? ▼
Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.. Recalled by Ranier's Compounding Laboratory. Units affected: 2 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 22, 2018. Severity: Moderate. Recall number: D-1094-2018.
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