Morphine Sulfate Tablet, Film Coated, Extended Release
FDA Recall NDC 43386-540
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Morphine Sulfate (NDC 43386-540). A significant event, classified as Class III, was initiated on Apr 10, 2019 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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 III Terminated
Failed Impurities/Degradation Specifications
Apr 10, 2019
May 01, 2019
3,444 bottles
Recall Profile & Regulatory Data
Event ID
82581
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Termination Date
Oct 14, 2022
Product Description
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01
Batch or Lot Expiration Information
Lot# : S700223 Exp. Apr 30 2019; S800467, Exp. Mar 31 2020.
Affected Packages Involved in this Recall
43386-540-01Product
43386-540-05Product
43386-541-01Product
43386-541-05Product
43386-542-01Product
43386-542-05Product
43386-543-01Product
43386-543-05Product
43386-544-01Product
43386-544-05Product
Class III Terminated
Failed Impurities/Degradation Specifications
Apr 10, 2019
May 01, 2019
324 bottles
Recall Profile & Regulatory Data
Event ID
82581
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Termination Date
Oct 14, 2022
Product Description
Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01
Batch or Lot Expiration Information
Lot# : S700224 Exp. Apr 30 2019; S800469 Exp. Mar 31 2020
Affected Packages Involved in this Recall
43386-540-01Product
43386-540-05Product
43386-541-01Product
43386-541-05Product
43386-542-01Product
43386-542-05Product
43386-543-01Product
43386-543-05Product
43386-544-01Product
43386-544-05Product
Class III Terminated
Failed Impurities/Degradation Specifications
Apr 10, 2019
May 01, 2019
17,328 bottles
Recall Profile & Regulatory Data
Event ID
82581
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Termination Date
Oct 14, 2022
Product Description
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
Batch or Lot Expiration Information
Lot# : S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020
Affected Packages Involved in this Recall
43386-540-01Product
43386-540-05Product
43386-541-01Product
43386-541-05Product
43386-542-01Product
43386-542-05Product
43386-543-01Product
43386-543-05Product
43386-544-01Product
43386-544-05Product
Class III Terminated
Failed Impurities/Degradation Specifications
Apr 10, 2019
May 01, 2019
10,284 bottles
Recall Profile & Regulatory Data
Event ID
82581
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Termination Date
Oct 14, 2022
Product Description
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01
Batch or Lot Expiration Information
Lot# : S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 2020
Affected Packages Involved in this Recall
43386-540-01Product
43386-540-05Product
43386-541-01Product
43386-541-05Product
43386-542-01Product
43386-542-05Product
43386-543-01Product
43386-543-05Product
43386-544-01Product
43386-544-05Product
Class III Terminated
Failed Impurities/Degradation Specifications
Apr 10, 2019
May 01, 2019
15,320 bottles
Recall Profile & Regulatory Data
Event ID
82581
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Termination Date
Oct 14, 2022
Product Description
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01
Batch or Lot Expiration Information
Lot# : S700221, Exp. Apr 30 2019; S700605, Exp. July 31 2019; S800232, Exp. Feb 29 2020.
Affected Packages Involved in this Recall
43386-540-01Product
43386-540-05Product
43386-541-01Product
43386-541-05Product
43386-542-01Product
43386-542-05Product
43386-543-01Product
43386-543-05Product
43386-544-01Product
43386-544-05Product
August 2018 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Aug 23, 2018
Sep 26, 2018
4716 bottle
Recall Profile & Regulatory Data
Event ID
80874
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Oct 14, 2022
Product Description
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
Batch or Lot Expiration Information
Lot# S800232, Exp 2/20
Affected Packages Involved in this Recall
43386-540-01Product
43386-540-05Product
43386-541-01Product
43386-541-05Product
43386-542-01Product
43386-542-05Product
43386-543-01Product
43386-543-05Product
43386-544-01Product
43386-544-05Product
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.
