NDC 54868-0021
Sulfamethoxazole and Trimethoprim 160 mg / 800 mg tablet
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-420.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 18, 2023 · 2 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Jul 7, 2021 · Class II · Aurobindo Pharma USA Inc.
Presence of Foreign Substance- Potential of metal contamination.
Lots: Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022 - Aug 10, 2020 · Class II · Aurobindo Pharma USA Inc.
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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sulfamethoxazole and Trimethoprim: every company that makes it
- Form
- tablet
- Strength
- 160 mg / 800 mg
- Approval
- ANDA ANDA090624
- On the market since
- Aug 11, 1995
- Package NDCs
54868-0021-054868-0021-154868-0021-254868-0021-354868-0021-454868-0021-554868-0021-654868-0021-7- Official label
- DailyMed (National Library of Medicine), updated Nov 23, 2010
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