Food, drugs, devices › Johnson Matthey Inc.
Drug recall: Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptf
Johnson Matthey Inc. (West Deptford, NJ) initiated this drug recall on 29 Aug 2019; FDA lists 3 product records under event 83457, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 21 Jan 2022. Initiation: voluntary: firm initiated. Johnson Matthey Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Johnson Matthey Inc., West Deptford, NJ.
Reason for recall
"cGMP Deviations: Potential glass contamination"
Distribution
"Nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1880-2019 | Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001. | 52882.23 grams | Class II | Terminated | 2 Oct 2019 |
| D-1881-2019 | Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001 | 26625 grams | Class II | Terminated | 2 Oct 2019 |
| D-1882-2019 | Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX | 316703.32 | Class II | Terminated | 2 Oct 2019 |
Context
Other enforcement events for Johnson Matthey Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Apr 2019 | Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass con | Drug | Class III | 1 |
| 5 Mar 2018 | Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 N | Drug | Class II | 1 |
All 3 events for Johnson Matthey Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP Deviations: Potential glass contamination"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jan 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.