Axia Pharmaceutical Recalls Biotin Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling Biotin Injectable Suspension due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are reported in the text, the 'lack of assurance of sterility' in an injectable product presents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls with potential for significant harm.
Plain-English summary
Axia Pharmaceutical, doing business as Fusion IV Pharmaceuticals, Inc., is recalling Biotin (Vitamin H) Injectable Suspension, 10 mg/mL, 30 mL multi-dose vials. The recall is being conducted due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # 11132019+53229 with an expiration date of 2/10/2020. The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
- Category
- Drug — Injectable
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 #: 11132019+53229
- Exp 2/10/2020
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.
See all 63 products in this recall →Related recalls
Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
See all →- Severe
- SevereAxia Pharmaceutical Recalls Selenium Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- Severe
- SevereAxia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- SevereAxia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
Same hazard · sterility
See all →- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- SevereSterling Recalls Carboxymethylcellulose Sodium Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereSterling Pharmaceutical Recalls Lubricating Tears Due to Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereWalgreens Lubricant Eye Drops Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2026-09-30
- SevereSodium Chloride Ophthalmic Solution Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereBiotin Solution for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2021-12-08
- SevereBiotin Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- HighMitomycin Injection Solution Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-01-18
- SevereAxium Healthcare Recalls Triamcinolone Hexacetonide Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-05-01
- SeverePartell Specialty Pharmacy Recalls Biotin Suspension Due to Sterility Concerns
FDA (Drugs) · 2018-04-25
- LowAuro Pharmacies Recalls Biotin Injection Vials for pH Failure
FDA (Drugs) · 2019-04-17