Auro Pharmacies Recalls Biotin Injection Vials for pH Failure
Auro Pharmacies Inc. is recalling 167 vials of Biotin 10 mg/mL Injection because the product failed to meet its pH label claim.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or manufacturing standards that is not likely to cause adverse health consequences.
Plain-English summary
Auro Pharmacies Inc. DBA Central Drugs is recalling 167 vials of Biotin 10 mg/mL Injection, 30 mL vial, Rx only. The recall was initiated because the product failed to meet its pH label claim, meaning it does not meet the specified pH requirements.
The affected product is identified by Lot 190205@1 with an expiry date of 08/4/19. The recall covers distribution nationwide within the United States.
Consumers and healthcare providers should stop using the affected vials and contact the recalling firm for further instructions or a return.
The recalled product
- Product
- Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
- Manufacturer
- Auro Pharmacies Inc. DBA Central Drugs
- Category
- Drug — Injection
- Hazard
- Affected units
- 167
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 190205@1
- expiry 08/4/19
Distribution
Distributed nationwide across the United States.
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