December 2021 FDA Recall Drug by Ideal Specialty Apothecary, Inc. Dba Ideal Pharmacy
D-0463-2022 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Ideal Specialty Apothecary, Inc. Dba Ideal Pharmacy on December 21, 2021 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0463-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
12-21-2021
Reported
02-09-2022
Quantity
57,994 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89270
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083

Batch or Lot Expiration Information

Lot# All lots within expiry