Acetaminophen And Codeine Phosphate Tablet
FDA Recall NDC 13107-059
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Acetaminophen And Codeine Phosphate (NDC 13107-059). A significant event, classified as Class II, was initiated on Mar 18, 2020 by Aurolife Pharma, Llc. The reported reason for this action was: "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
57337 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
Batch or Lot Expiration Information
Lot# : 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
Affected Packages Involved in this Recall
13107-058-30Product
13107-058-01Product
13107-058-05Product
13107-058-99Product
13107-059-30Product
13107-059-01Product
13107-059-05Product
13107-059-99Product
13107-060-30Product
13107-060-01Product
13107-060-05Product
13107-060-99Product
Class II Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
4332 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
Batch or Lot Expiration Information
Lot# : 059180023A, 059180024A and 059180025A, Exp. Date 05/2021
Affected Packages Involved in this Recall
13107-058-30Product
13107-058-01Product
13107-058-05Product
13107-058-99Product
13107-059-30Product
13107-059-01Product
13107-059-05Product
13107-059-99Product
13107-060-30Product
13107-060-01Product
13107-060-05Product
13107-060-99Product
Class II Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mar 18, 2020
Apr 22, 2020
14194 units
Recall Profile & Regulatory Data
Event ID
85183
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Mar 25, 2024
Product Description
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Batch or Lot Expiration Information
Lot# : 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021
Affected Packages Involved in this Recall
13107-058-30Product
13107-058-01Product
13107-058-05Product
13107-058-99Product
13107-059-30Product
13107-059-01Product
13107-059-05Product
13107-059-99Product
13107-060-30Product
13107-060-01Product
13107-060-05Product
13107-060-99Product
Class II Terminated
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).
Apr 24, 2018
May 23, 2018
1 20-count containers
Recall Profile & Regulatory Data
Event ID
79961
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Prescript Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
California.
Termination Date
Jan 23, 2019
Product Description
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033
Batch or Lot Expiration Information
Lot# 0130131, EXP 8/31/20
Affected Packages Involved in this Recall
13107-058-30Product
13107-058-01Product
13107-058-05Product
13107-058-99Product
13107-059-30Product
13107-059-01Product
13107-059-05Product
13107-059-99Product
13107-060-30Product
13107-060-01Product
13107-060-05Product
13107-060-99Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
