Axia Pharmaceutical Recalls MIC-PLEX Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling MIC-PLEX Injection in the U.S., Puerto Rico, Barbados, and the Dominican Republic due to a lack of assurance of 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 severity score under the rubric for significant injury or property damage reports.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling MIC-PLEX Injection, a vitamin complex intended for intramuscular use. The recall is being conducted because of a lack of assurance of sterility.
The affected product is distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic. The specific lots involved are 11212019+53263 (expiring 2/16/2020) and 11252019+53276 (expiring 2/20/2020).
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions.
The recalled product
- Product
- MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0233-3
- Category
- Drug — Injection
- 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 (4)
- Lot #: 11212019+53263
- Exp 2/16/2020
- 11252019+53276
- Exp 2/20/2020
Distribution
Part of a larger recall action
This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical 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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