D-1880-2019 Class II Terminated
FDA drug recall D-1880-2019 was initiated by Johnson Matthey Inc. on August 29, 2019 and is designated Class II. Reason for recall: cGMP Deviations: Potential glass contamination The recall status is terminated (terminated January 21, 2022). Affected quantity: 52882.23 grams.
Recall Details
- Product Type
- Drugs
- Report Date
- October 2, 2019
- Initiation Date
- August 29, 2019
- Termination Date
- January 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52882.23 grams
Product Description
Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.
Reason for Recall
cGMP Deviations: Potential glass contamination
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: B0030-180101, B0030-180102, Exp. Feb 2023