Medroxyprogesterone acetate injectable vials recalled for lack of sterility assurance
Sun Pharmaceutical is recalling 26,892 vials of medroxyprogesterone acetate injectable suspension (150 mg/mL) distributed nationwide due to lack of assurance of sterility. The affected lots expire between January and June 2023.
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 injectable drug recall with documented sterility deficiency. Although no illnesses or injuries have been reported, non-sterile injectable medications pose significant risk of serious infection, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling medroxyprogesterone Acetate Injectable Suspension, USP (150 mg/mL) distributed nationwide. The recall involves 26,892 vials packaged in 25-count cartons with NDC number 16714-090-40. Three production lots are affected: HAC2074A (expiration 06/2023), HAC0163B (expiration 01/2023), and HAC1741A (expiration 04/2023).
The recall was initiated due to lack of assurance of sterility. Sterility is a critical requirement for injectable medications to prevent serious infections and other adverse health effects.
Healthcare providers and patients who may have received injections from the affected lots should consult their healthcare provider. The product is manufactured by Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey.
The recalled product
- Product
- 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…
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable Suspension
- Affected units
- 26,892
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 (5)
- Lot#: HAC2074A
- Exp Date 06/2023
- HAC0163B
- Exp Date 01/2023 & HAC1741A
- Exp Date 04/2023
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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