Ranier's Triple P Injection Recalled for Sterility Assurance Concerns
Ranier's Compounding Laboratory is recalling Triple P Injection due to practices that may call into question the sterility of the product.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility assurance issues for injectable products.
Plain-English summary
Ranier's Compounding Laboratory is recalling Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL. The product is packaged in 5 mL and 10 mL vials and is available by prescription only. The recall was initiated because practices at the firm may call into question the sterility of products intended to be sterile.
The affected product was distributed within the state of Pennsylvania. All lots within the expiry date are included in this recall. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
- Manufacturer
- Ranier's Compounding Laboratory
- Category
- Drug — Injectable
- Hazard
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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