NDC 45865-466

Acetaminophen and Codeine Phosphate 60 mg / 300 mg tablet

On the label: Medsource Pharmaceuticals. It's repackaged: Medsource Pharmaceuticals rebottles it from Aurolife Pharma LLC's NDC 13107-060.

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

Medsource Pharmaceuticals, Rancho Santa Margarita, CA, United States · repackages it

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.

Generic drug: Acetaminophen and Codeine: every company that makes it
Form: tablet
Strength: 60 mg / 300 mg
Approval: ANDA ANDA202800
On the market since: Apr 15, 2013
Package NDCs: 45865-466-30 45865-466-60
Official label: DailyMed (National Library of Medicine), updated Jul 24, 2018

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