Ranier's Compounding Laboratory Recalls Papaverine/Phentolamine Injection Due to Sterility Concerns
Ranier's Compounding Laboratory is recalling Papav 300/Phent 5mg/10mL Injection due to lack of assurance of sterility. The product was distributed in Pennsylvania.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility issues in injectable drugs) are classified as Severe.
Plain-English summary
Ranier's Compounding Laboratory is recalling Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection, 300 mg/5 mg/10 mL, 10 mL vial. The recall is being conducted because practices at the firm may call into question the sterility of products intended to be sterile.
The affected product is prescription-only and was distributed within the state of Pennsylvania. The recall includes all lots within expiry.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Ranier's Compounding Laboratory
- Category
- Drug — Injectable
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 15 recalled by Ranier's Compounding Laboratory under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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