Home / Recalls / LUPIN SOMERSET / D-1214-2018

D-1214-2018 Class III Terminated

Recalled by LUPIN SOMERSET — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
September 26, 2018
Initiation Date
August 23, 2018
Termination Date
October 14, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4716 bottle

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

Reason for Recall

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.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot# S800232, Exp 2/20

Other recalls by LUPIN SOMERSET

  • D-1244-2019 Class III — Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Ma (April 10, 2019)
  • D-1246-2019 Class III — Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, M (April 10, 2019)
  • D-1247-2019 Class III — Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactur (April 10, 2019)
  • D-1243-2019 Class III — Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Ma (April 10, 2019)
  • D-1245-2019 Class III — Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Ma (April 10, 2019)
  • D-1113-2019 Class II — Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride (March 19, 2019)
  • D-0390-2019 Class II — Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Man (January 15, 2019)
  • D-0346-2019 Class II — Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactu (December 21, 2018)
  • D-0092-2019 Class II — Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured fo (October 5, 2018)
  • D-0927-2018 Class II — Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactur (June 28, 2018)