D-1147-2022 Class II Terminated
FDA drug recall D-1147-2022 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: 26892 vials.
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
- 26892 vials
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.
Reason for Recall
Lack of assurance of sterility
Distribution Pattern
USA Nationwide
Code Information
Lot#: HAC2074A, Exp Date 06/2023; HAC0163B, Exp Date 01/2023 & HAC1741A, Exp Date 04/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1147-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026