The Recall Desk
LowFDA (Drugs)·D-1082-2019·Announced 2019-04-17

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.

What this means for you

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.
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.