March 2019 FDA Recall Drug by Auro Pharmacies Inc. Dba Central Drugs
D-1082-2019 - Failed pH Specification

This Class III drug recall was voluntarily initiated by Auro Pharmacies Inc. Dba Central Drugs on March 22, 2019 for the product Drug. The FDA reported the reason for recall as failed ph specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1082-2019

Reason for Recall
Failed pH Specification: product does not meet pH label claim.
Initiated
03-22-2019
Reported
04-17-2019
Quantity
167 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82483
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Auro Pharmacies Inc. DBA Central Drugs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2020
Product Description About Product Description
Full technical description of the product.
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.

Batch or Lot Expiration Information

Lot# Lot 190205@1, expiry 08/4/19