Medroxyprogesterone Acetate Injectable Suspension Recalled for Sterility Assurance Failure
Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension due to lack of assurance of sterility. The recall affects approximately 57,997 prefilled syringes distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable medication with sterility assurance failure. Meets the High severity criterion: risk-of-harm product where injury has not yet been reported. Sterility failure in injectable medications could lead to serious infection, but no illnesses have been reported.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling medroxyprogesterone acetate injectable suspension, USP 150 mg/mL in 1 mL prefilled syringes due to lack of assurance of sterility. This is a prescription contraceptive injection used for birth control and other medical purposes.
The recall was initiated because the manufacturer could not assure that the affected batches met sterility standards required for injectable medications. Medroxyprogesterone acetate is injected directly into the body, making sterility critical to prevent injection-site infections and other serious complications.
The recall affects four lots: HAC1289A (expiration 06/2023), JKX2679A (expiration 06/2022), JKX3762A (expiration 08/2022), and HAC0164A (expiration 06/2023). Approximately 57,997 prefilled syringes have been distributed nationwide.
Patients who have received an injection from the affected lots should consult their healthcare provider. Do not use syringes from the recalled lots. Contact Sun Pharmaceutical or your pharmacy for replacement product or alternative contraceptive options.
The recalled product
- Product
- 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.
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable Contraceptive
- Hazard
- Affected units
- 57,997
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot#: HAC1289A
- Exo 06/2023
- JKX2679A
- Exp 06/2022
- JKX3762A
- Exp 08/2022
- HAC0164A
- Exp 06/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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