NDC 71335-0336

Acetaminophen and Codeine Phosphate 60 mg / 300 mg tablet

On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Aurolife Pharma LLC's NDC 13107-060.

Where the pills inside were made

Repackaging site

• Bryant Ranch Prepack, Burbank, CA, 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, oral

Strength

60 mg / 300 mg

Approval

ANDA ANDA202800

On the market since

Apr 15, 2013

Package NDCs

71335-0336-0 71335-0336-1 71335-0336-2 71335-0336-3 71335-0336-4 71335-0336-5 71335-0336-6 71335-0336-7 71335-0336-8 71335-0336-9

Official label

DailyMed (National Library of Medicine), updated Aug 9, 2024

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