Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 M
Summary
The FDA issued a Class II for Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Do by Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0463-2022
Action Date
2022-02-09
Status
Ongoing
Category
drug
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
Lot/Code Info: All lots within expiry
Quantity Affected: 57,994 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-21
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy have FDA actions?
This is the only FDA action we have on record for Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0463-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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