medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Nor
Summary
The FDA issued a Class II for medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 1 by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Lack of assurance of sterility.
Details
Source
Drug Recall
External ID
D-1146-2022
Action Date
2022-06-22
Status
Terminated
Category
drug
Product Description
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01.
Lot/Code Info: Lot: HAC2075A, Exp 06/2023; HAC2076A, Exp 07/2023; HAC2077A, HAC2078A, Exp 08/2023; HAC3803A, Exp 09/2023; HAC0551A, Exp 02/2023; HAC0562A, HAC1183A, Exp 03/2023; HAC1807A, Exp 06/2023; JKX6017A, JKX6018A Exp 12/2022; HAC0163A, Exp 01/2023; HAC1184A, Exp 04/2023; HAC0162A, Exp 12/2022.
Quantity Affected: 180813 syringes
Reason for Recall
Lack of assurance of sterility
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-06
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1146-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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