D-1146-2022 Class II Terminated
FDA drug recall D-1146-2022 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: 180813 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
- 180813 syringes
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01.
Reason for Recall
Lack of assurance of sterility
Distribution Pattern
USA Nationwide
Code Information
Lot: HAC2075A, Exp 06/2023; HAC2076A, Exp 07/2023; HAC2077A, HAC2078A, Exp 08/2023; HAC3803A, Exp 09/2023; HAC0551A, Exp 02/2023; HAC0562A, HAC1183A, Exp 03/2023; HAC1807A, Exp 06/2023; JKX6017A, JKX6018A Exp 12/2022; HAC0163A, Exp 01/2023; HAC1184A, Exp 04/2023; HAC0162A, Exp 12/2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1146-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026