D-1144-2022 Class II Terminated
FDA drug recall D-1144-2022 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: 57997 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
- 57997 syringes
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.
Reason for Recall
Lack of assurance of sterility
Distribution Pattern
USA Nationwide
Code Information
Lot#: HAC1289A, Exo 06/2023; JKX2679A, Exp 06/2022; JKX3762A, Exp 08/2022; HAC0164A, 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-1144-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026