Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044

FDA recall notice · announced May 15, 2019 · Par Pharmaceutical

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044

Reason for recall

Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product

Notes

Distribution: nationwide
Lot/code information: AD812, exp 9/2020
Quantity: 4506 packs
Status: Terminated
Products in this recall event:
- Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044 (D-1293-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.