D-1143-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2022
- Initiation Date
- May 6, 2022
- Termination Date
- August 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;