Axia Pharmaceutical Recalls B-Complex 110 Injectable Due to Sterility Concerns
Axia Pharmaceutical is recalling B-Complex 110 Injectable vials due to a lack of assurance of sterility. The affected lots were distributed nationwide and in several international locations.
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 B-Complex 110 Injectable. The product is a 30 mL multi-dose vial intended for intravenous, intramuscular, or subcutaneous use and is available by prescription only. The recall is being conducted because of a lack of assurance of sterility.
The affected product includes NDC 71283-0212-3. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in March, April, and August 2020. The product was distributed in the United States, Puerto Rico, Barbados, and the Dominican Republic.
Healthcare providers and patients should stop using the affected lots of B-Complex 110 Injectable. Consumers should consult their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled medication.
The recalled product
- Product
- B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3
- Category
- Drug — Injectable Medication
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 (8)
- Lot #: 07022019+52584
- 07022019+52579
- Exp 3/29/2020
- 08012019+52780
- 08012019+52782
- Exp 4/28/2020
- 11262019+53288
- Exp 8/23/2020
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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