Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns
Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised the product's sterility.
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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Liberty Drug & Surgical is recalling specific lots of Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials. The recall is due to process deficiencies observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
The affected product is prescription-only and was distributed to physicians, medical facilities, and specific patients in New Jersey and New York. The recall covers two specific lots: Lot 05112015@3 (Expiration 06/25/15) and Lot 06012015@12 (Expiration 07/17/15).
Patients and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
- Manufacturer
- Liberty Drug & Surgical
- Category
- Drug — Injectable
- Affected units
- 4
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 (4)
- Lot #: 05112015@3
- Exp 06/25/15
- 06012015@12
- Exp 07/17/15
Distribution
Part of a larger recall action
This product is one of 25 recalled by Liberty Drug & Surgical 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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