FDA Recall D-0463-2022
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy · Union, NJ
Class II Ongoing 1605 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0463-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- nationwide in the USA
- Recall initiated
- 2021-12-21
- Classified by FDA Center
- 2022-01-31
- FDA published
- 2022-02-09
- Recalling firm
- Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
- Firm location
- Union, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.