Ropinirole Tablet, Film Coated
FDA Recall NDC 16729-237
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 7 recorded enforcement report(s) associated with Ropinirole (NDC 16729-237). A significant event, classified as Class II, was initiated on Feb 07, 2023 by Accord Healthcare Inc.. The reported reason for this action was: "CGMP Deviations: recalling drug products following an FDA inspection."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
8,184 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC 3 16729 23701 7
Batch or Lot Expiration Information
Batch# Batches: P2106136, Exp. Date 8/31/2023, P2106813, P2106814, Exp. Date 9/30/2023, P2202764, Exp. Date 4/30/2024
Affected Packages Involved in this Recall
16729-232-01Product
16729-233-01Product
16729-234-01Product
16729-235-01Product
16729-236-01Product
16729-237-01Product
16729-238-01Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
139,332 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2;
Batch or Lot Expiration Information
Batch# Batches: P2102086, Exp. Date 3/31/2023; P2105094, P2105095, P2105097, P2105096, P2105093, Exp. Date 7/31/2023; P2106490, P2106491, P2106493, P2106492, P2106494, Exp. Date 9/30/2023; P2201069, P2201068, P2201067, Exp. Date 1/31/2024; P2203516, Exp. Date 5/31/2024
Affected Packages Involved in this Recall
16729-232-01Product
16729-233-01Product
16729-234-01Product
16729-235-01Product
16729-236-01Product
16729-237-01Product
16729-238-01Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
5,112 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC 3 16729 23801 4
Batch or Lot Expiration Information
Batch# Batches: P2104150, P2104151, Exp. Date 6/30/2023, P2202065, Exp. Date 3/31/2024
Affected Packages Involved in this Recall
16729-232-01Product
16729-233-01Product
16729-234-01Product
16729-235-01Product
16729-236-01Product
16729-237-01Product
16729-238-01Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
14,928 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC 3 16729 23601 0
Batch or Lot Expiration Information
Batch# Batches: P2105099, P2105098, Exp. Date 7/31/2023, P2106507, P2106508, P2106510, P2106509, Exp. Date 9/30/2023, P2202750, Exp. Date 4/30/2024
Affected Packages Involved in this Recall
16729-232-01Product
16729-233-01Product
16729-234-01Product
16729-235-01Product
16729-236-01Product
16729-237-01Product
16729-238-01Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
25,344 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3
Batch or Lot Expiration Information
Batch# Batches: P2106370, P2106369, Exp. Date 9/30/2023, P2201254, Exp. Date 2/29/2024
Affected Packages Involved in this Recall
16729-232-01Product
16729-233-01Product
16729-234-01Product
16729-235-01Product
16729-236-01Product
16729-237-01Product
16729-238-01Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
104,945 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6
Batch or Lot Expiration Information
Batch# Batches: P2103544 Exp. Date 5/31/2023, P2106132, P2106131, P2106128, P2106129, P2106130, P2106133, Exp. Date 8/31/2023, P2107662, P2107663, P2107664, Exp. Date 11/30/2023, P2203543, Exp. Date 5/31/2024
Affected Packages Involved in this Recall
16729-232-01Product
16729-233-01Product
16729-234-01Product
16729-235-01Product
16729-236-01Product
16729-237-01Product
16729-238-01Product
Class II Terminated
CGMP Deviations: recalling drug products following an FDA inspection.
Feb 07, 2023
Mar 08, 2023
181,848 bottles
Recall Profile & Regulatory Data
Event ID
91657
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Accord Healthcare, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States including Puerto Rico and Canada
Termination Date
Apr 22, 2024
Product Description
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9
Batch or Lot Expiration Information
Batch# Batches: P2102133, P2102135, P2102136, Exp. Date 3/31/2023, P2104998, P2104997, P2104991, P2104992, P2104990, P2104993, P2105000, P2104999, P2105002, P2105001, Exp. Date 7/31/2023, P2106812, Exp. Date, 9/30/2023, P2200433, P2200434, P2200435, Exp. Date, 12/31/2023, P2202730, P2202729, Exp. Date 4/30/2024, P2203517, Exp. Date 5/31/2024
Affected Packages Involved in this Recall
16729-232-01Product
16729-233-01Product
16729-234-01Product
16729-235-01Product
16729-236-01Product
16729-237-01Product
16729-238-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
