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Class II: temporary or reversible health riskOngoing

Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy Medroxyprogesterone Acetate Injection Recall

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

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

Risk level
Class II
Reported by FDA
Feb 9, 2022
Recall ID
D-0463-2022
Check your lot numberHow we source this data

Summary

Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy recalled Medroxyprogesterone Acetate Injection starting Dec 21, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0463-2022 on Feb 9, 2022. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

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 numbers, UPCs & expiration codes

All lots within expiry

Where it was sold

nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0463-2022
Classification
Class II
Status
Ongoing
Recall initiated
Dec 21, 2021
FDA report date
Feb 9, 2022
Quantity
57,994 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy

Original FDA data

Every field from FDA enforcement report D-0463-2022, exactly as published.

Show all FDA fields
City
Union
State
NJ
Status
Ongoing
Country
United States
Event ID
89270
Address
2333 Morris Ave Ste B101
Code information
All lots within expiry
Postal code
07083-5716
Report date
Feb 9, 2022
Product type
Drugs
Recall number
D-0463-2022
Classification
Class II
Recalling firm
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
Product quantity
57,994 vials
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
nationwide in the USA
Recall initiation date
Dec 21, 2021
Initial firm notification
Letter
Center classification date
Jan 31, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0463-2022, published Feb 9, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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