Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only,...

FDA Recall #D-0463-2022 — Class II — December 21, 2021

Recall #D-0463-2022 Date: December 21, 2021 Classification: Class II Status: Ongoing

Product Description

Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy — Union, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

57,994 vials

Distribution

nationwide in the USA

Code Information

All lots within expiry

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated