NDC 72189-042
Cefdinir 125 mg per 5 mL powder, for suspension
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-722.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Mandideep, India | Makes it and packages it | Serious problems, FDA actionNov 23, 2022 · 6 inspections, 3 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- May 8, 2024 · Class II · Lupin Pharmaceuticals Inc.
Defective container: lack of seal integrity.
Lots: Lot #F305184, F305185, F305186, Exp 7/31/ 2025 - Apr 24, 2024 · Class II · Lupin Pharmaceuticals Inc.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lots: Lot # F305442, Exp 8/30/2025 - Apr 24, 2024 · Class II · Lupin Pharmaceuticals Inc.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lots: Lot # F305292, Exp 8/30/2025 - Jul 2, 2020 · Class II · Lupin Pharmaceuticals Inc.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Lots: Lot # F802189, Exp 10/2020, F900240, Exp 1/2021 - Nov 1, 2019 · Class III · Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.
Lots: Lot #: F802345, F802346, F802347, Exp 11/20 - Nov 1, 2019 · Class III · Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.
Lots: Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20 - May 23, 2019 · Class II · Lupin Pharmaceuticals Inc.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Lots: Lot # F802335, exp. date November 2020 - Jan 2, 2019 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Lots: a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, … - Jan 2, 2019 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Lots: a) Lot #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b) Lot #: F700324, F700325, F700326, Exp. January 2019; F700618, F700619,… - Mar 27, 2018 · Class II · Lupin Pharmaceuticals Inc.
Superpotent Drug
Lots: Lot # F602241; Exp. 10/18 Lot # F602577; Exp. 11/18 Lot # F700036; Exp. 12/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cefdinir: every company that makes it
- Form
- powder, for suspension
- Strength
- 125 mg per 5 mL
- Approval
- ANDA ANDA065259
- On the market since
- Sep 17, 2019
- Package NDCs
72189-042-32- Official label
- DailyMed (National Library of Medicine), updated Sep 17, 2019
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