NDC 61919-053
Acetaminophen And Codeine Phosphate 30 mg / 300 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurolife Pharma LLC's NDC 13107-059.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it and relabels it
Recalls
- Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021 - Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 059180023A, 059180024A and 059180025A, Exp. Date 05/2021 - Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021 - Apr 24, 2018 · Class II · Prescript Pharmaceuticals, Inc.
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Lots: Lot # 0130131, EXP 8/31/20
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetaminophen and Codeine: every company that makes it
- Form
- tablet
- Strength
- 30 mg / 300 mg
- Approval
- ANDA ANDA202800
- On the market since
- Feb 13, 2017
- Package NDCs
61919-053-60- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2020
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