D-1143-2022 Class II Terminated
FDA drug recall D-1143-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on May 6, 2022 and is designated Class II. Reason for recall: Lack of assurance of sterility The recall status is terminated (terminated Aug 14, 2023). Affected quantity: 79339 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 22, 2022
- Initiation Date
- May 6, 2022
- Termination Date
- Aug 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79339 syringes
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.
Reason for Recall
Lack of assurance of sterility
Distribution Pattern
USA Nationwide
Code Information
Lots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, Exp 06/2023;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1143-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026