Martin Avenue Pharmacy Recalls PGE 2 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling PGE 2 injectable vials due to quality control issues affecting sterility assurance.
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 severity score under the rubric for significant injury/property-damage reports or high-risk defects.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of PGE 2, 100 mcg/mL injectable packaged in clear glass vials. The recall covers all compounded sterile preparations within their expiry date.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These issues present a risk to the assurance of sterility for the affected products.
The affected product is distributed nationwide. Consumers and healthcare providers should stop using the recalled PGE 2 injectable vials and contact Martin Avenue Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- 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 (2)
- Lot Number: 06232014@47
- Exp 9/21/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. 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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