NDC 71335-1188
ropinirole 0.5 mg tablet, film coated
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Accord Healthcare Inc.'s NDC 16729-233.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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 4/3… - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: 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 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2106370, P2106369, Exp. Date 9/30/2023, P2201254, Exp. Date 2/29/2024 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2105099, P2105098, Exp. Date 7/31/2023, P2106507, P2106508, P2106510, P2106509, Exp. Date 9/30/2023, P2202750, Exp. Date 4/30/2024 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2106136, Exp. Date 8/31/2023, P2106813, P2106814, Exp. Date 9/30/2023, P2202764, Exp. Date 4/30/2024 - Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: P2104150, P2104151, Exp. Date 6/30/2023, P2202065, Exp. Date 3/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ropinirole: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 0.5 mg
- Approval
- ANDA ANDA204022
- On the market since
- Oct 17, 2018
- Package NDCs
71335-1188-171335-1188-271335-1188-371335-1188-471335-1188-5- Official label
- DailyMed (National Library of Medicine), updated Oct 31, 2024
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