Liberty Drug Recalls Papervine Injectable Due to Sterility Concerns
Liberty Drug & Surgical is recalling Papervine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 risk of serious injury (infection) due to compromised sterility in an injectable product, meeting the criteria for a Severe rating.
Plain-English summary
Liberty Drug & Surgical is recalling 2.5 mL vials of Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL. The recall involves Lot # 06022015@5, which expires in July 2015. The product is a prescription-only injectable manufactured by Liberty Drug Compound Center in Chatham, New Jersey.
The recall was initiated due to process deficiencies observed in the sterile ophthalmic and injectable products. These deficiencies could have compromised the sterility of the product, posing a risk of infection or other adverse health consequences to patients.
The affected product was distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. Patients who have received this medication should contact their healthcare provider for guidance on whether to discontinue use or seek alternative treatment.
The recalled product
- Product
- Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
- Manufacturer
- Liberty Drug & Surgical
- 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 (2)
- Lot #: 06022015@5
- 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.
See all 25 products in this recall →Related recalls
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