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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90151

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 06, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SUN PHARMACEUTICAL INDUSTRIES INC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 5

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 of Italy, NDC 50102-591-40.

D-1143-2022
Recall number
D-1143-2022
Initiated
May 06, 2022
Classification
Class II
Status
Terminated
Quantity
79339 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

Lots#: JKX4312A & JKX4313A, Exp 09/2022; JKX4827A, Exp 09/2023; HAC1290A & HAC2082B, Exp 06/2023;

Distribution pattern

USA Nationwide

drug · product 2 of 5

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.

D-1144-2022
Recall number
D-1144-2022
Initiated
May 06, 2022
Classification
Class II
Status
Terminated
Quantity
57997 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

Lot#: HAC1289A, Exo 06/2023; JKX2679A, Exp 06/2022; JKX3762A, Exp 08/2022; HAC0164A, Exp 06/2023.

Distribution pattern

USA Nationwide

drug · product 3 of 5

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: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 62756-091-40.

D-1145-2022
Recall number
D-1145-2022
Initiated
May 06, 2022
Classification
Class II
Status
Terminated
Quantity
4625 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

Lot #: HAC1951A, Exp 06/2023

Distribution pattern

USA Nationwide

drug · product 4 of 5

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.

D-1146-2022
Recall number
D-1146-2022
Initiated
May 06, 2022
Classification
Class II
Status
Terminated
Quantity
180813 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

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.

Distribution pattern

USA Nationwide

drug · product 5 of 5

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 , NDC 16714-090-40 packaged in 25 count carton.

D-1147-2022
Recall number
D-1147-2022
Initiated
May 06, 2022
Classification
Class II
Status
Terminated
Quantity
26892 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility

Code information

Lot#: HAC2074A, Exp Date 06/2023; HAC0163B, Exp Date 01/2023 & HAC1741A, Exp Date 04/2023

Distribution pattern

USA Nationwide