Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns
Liberty Drug & Surgical is recalling specific lots of Papaverine/Phentolamine/Atropine/PGE-1 Injectable due to process deficiencies that could compromise 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. According to the rubric, FDA Class II recalls with potential for significant injury (such as sterility compromise in injectables) are categorized as Severe (Score 4).
Plain-English summary
Liberty Drug & Surgical is recalling 6 vials of Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial. The affected lots are 04202015@18 (Exp 06/04/15) and 05192015@16 (Exp 07/03/15). The product is prescription-only and was distributed to physicians, medical facilities, and specific patients in New Jersey and New York.
The recall was initiated because process deficiencies were 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.
Patients and healthcare providers who have received this product should contact their healthcare provider for guidance on alternative treatments or further evaluation. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 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
- 6
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 #: 04202015@18
- Exp 06/04/15
- 05192015@16
- Exp 07/03/15
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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