Axia Pharmaceutical Recalls Cyanocobalamin Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Cyanocobalamin Injection because the product lacks 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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Cyanocobalamin Injection, 2000 mcg/mL. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product is a 30 mL multi-dose vial intended for intravenous, intramuscular, or subcutaneous use. The recall covers lots 07172019+52695, 07172019+52697, and 07252019+52759, which have an expiration date of January 25, 2020.
The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3
- Category
- Drug — Injectable
- 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 #:07172019+52695
- 07172019+52697
- 07252019+52759
- Exp 1/25/2020
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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