Prefilled Syringes of Medroxyprogesterone Acetate Recalled for Lack of Sterility Assurance
Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were 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 for an injectable pharmaceutical product where the manufacturer could not provide assurance of sterility. While no contamination has been confirmed and no illnesses have been reported, injectable medications represent a significant risk-of-harm if contaminated, warranting a High severity rating.
Plain-English summary
Sun Pharmaceutical Industries, Inc., and its US distributor Afaxys Pharma, LLC, are recalling 79,339 prefilled syringes containing medroxyprogesterone acetate injectable suspension, 150 mg/mL. The product is a prescription-only contraceptive injection with NDC 50102-591-40.
The recall was initiated because the manufacturer could not provide assurance that all syringes in the affected lots were sterile. This lack of sterility assurance means the product does not meet required safety standards for injectable medications.
The recalled syringes were distributed nationwide across the United States. The affected lot numbers are JKX4312A and JKX4313A (expiration 09/2022), JKX4827A (expiration 09/2023), and HAC1290A and HAC2082B (expiration 06/2023).
Patients who have received injections from these lots should contact their healthcare provider if they experience signs of infection, such as redness, swelling, warmth, or drainage at the injection site. Unused syringes should not be used and should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- 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…
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable Contraceptive
- Affected units
- 79,339
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 (6)
- Lots#: JKX4312A & JKX4313A
- Exp 09/2022
- JKX4827A
- Exp 09/2023
- HAC1290A & HAC2082B
- 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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