Medroxyprogesterone Acetate Injectable Suspension Recalled for Sterility Concerns
Sun Pharmaceutical is recalling 4,625 syringes of Medroxyprogesterone Acetate Injectable Suspension (Lot HAC1951A) due to lack of assurance of sterility. The affected medication was 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 with documented lack of sterility assurance in an injectable medication. No illnesses or injuries have been reported, and no hospitalizations are documented, making this a risk-of-harm product without reported injury, consistent with High severity per the rubric.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg/mL in 1 mL prefilled syringes (Lot HAC1951A, expiration 06/2023, NDC 62756-091-40) due to lack of assurance of sterility.
Approximately 4,625 syringes were distributed nationwide in the United States. Patients who may have received medication from this lot should contact their healthcare provider or pharmacy for guidance regarding use of the affected product.
The recalled product
- Product
- MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE)
- Brand
- MEDROXYPROGESTERONE ACETATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable / Hormone
- Affected units
- 4,625
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 (2)
- Lot #: HAC1951A
- 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.
See all 5 products in this recall →Related recalls
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