Home / Recalls / Johnson Matthey Inc. / D-1077-2019

D-1077-2019 Class II Terminated

Recalled by Johnson Matthey Inc. — West Deptford, NJ

Recall Details

Product Type
Drugs
Report Date
April 10, 2019
Initiation Date
March 5, 2018
Termination Date
July 23, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
169.976 kg

Product Description

Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

Reason for Recall

Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.

Distribution Pattern

Nationwide in the US

Code Information

Lot# B1414-160809, Retest Date AUG 2021

Other recalls by Johnson Matthey Inc.

  • D-1881-2019 Class II — Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Mater (August 29, 2019)
  • D-1880-2019 Class II — Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutica (August 29, 2019)
  • D-1882-2019 Class II — Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Mat (August 29, 2019)
  • D-1252-2019 Class III — Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, proce (April 2, 2019)