Liberty Drug Recalls Papaverine/Phentolamine/PGE-1 Injectable Due to Sterility Concerns
Liberty Drug & Surgical is recalling 2 vials of Papaverine/Phentolamine/PGE-1 Injectable 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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility compromise in an injectable product.
Plain-English summary
Liberty Drug & Surgical is recalling 2 vials of Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only. The product is identified by Lot # 05282015@7 and has an expiration date of 07/13/15.
The recall was initiated due to process deficiencies observed in sterile ophthalmic and injectable products that could have compromised the sterility of the product. This lack of assurance of sterility presents a potential risk to patients using the medication.
The affected product was distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. Patients 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
- Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 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
- Hazard
- 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 #: 05282015@7
- Exp 07/13/15
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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