Multi-event April 2019 FDA Recall Morphine Sulfate by Lupin Somerset
This Multi-event Class III drug recall was voluntarily initiated by Lupin Somerset on April 10, 2019 for the product Morphine Sulfate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1246-2019
Failed Impurities/Degradation Specifications
04-10-2019
05-01-2019
3,444 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
LUPIN SOMERSET
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1247-2019
Failed Impurities/Degradation Specifications
04-10-2019
05-01-2019
324 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
LUPIN SOMERSET
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1243-2019
Failed Impurities/Degradation Specifications
04-10-2019
05-01-2019
17,328 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
LUPIN SOMERSET
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1245-2019
Failed Impurities/Degradation Specifications
04-10-2019
05-01-2019
10,284 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
LUPIN SOMERSET
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1244-2019
Failed Impurities/Degradation Specifications
04-10-2019
05-01-2019
15,320 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
LUPIN SOMERSET
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
10-14-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
