D-0774-2022 Class II Terminated
FDA drug recall D-0774-2022 was initiated by Mylan Pharmaceuticals Inc on Apr 7, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing. The recall status is terminated (terminated May 23, 2023). Affected quantity: 33,893 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 27, 2022
- Initiation Date
- Apr 7, 2022
- Termination Date
- May 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,893 vials
Product description
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Distribution pattern
Nationwide in the USA
Code information
Lot #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0774-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026