Apl Healthcare Limited
Mahabubnagar, India · makes it and tests it
No problems found Last FDA inspection Jan 18, 2023. 2 inspections on record.
NDC 50436-4694
Sulfamethoxazole and Trimethoprim 80 mg / 400 mg tablet
On the label: Unit Dose Services.
It's a repackaged product: Unit Dose Services rebottles it from Aurobindo Pharma Limited's NDC 65862-419.
Where the pills inside were made
Aurobindo Pharma Limited
Medchal, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Jul 21, 2023. 13 inspections on record, 1 with serious problems.
Aurobindo Pharma Limited
Mahabubnagar, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection May 10, 2022. 7 inspections on record, 1 with serious problems.
Repackaging site
- Unit Dose Services, · repackages it and relabels it
Recalls
- Jul 7, 2021 · Class II · Terminated
Presence of Foreign Substance- Potential of metal contamination.
Lots: Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022 - Aug 10, 2020 · Class II · Terminated
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Lots: Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.
Product details
- Generic drug
- Sulfamethoxazole and Trimethoprim: see every company that makes it
- Form
- tablet
- Strength
- 80 mg / 400 mg
- Approval
- ANDA ANDA090624
- On the market since
- Feb 16, 2010
- Package NDCs
50436-4694-1- Official label
- DailyMed (National Library of Medicine), updated Mar 6, 2017
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