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
Reported: May 15, 2019 Initiated: April 30, 2019 #D-1293-2019
Product Description
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
Details
- Recalling Firm
- Par Pharmaceutical, Inc.
- Units Affected
- 4506 packs
- Distribution
- nationwide
- Location
- Chestnut Ridge, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Par Pharmaceutical, Inc.. Units affected: 4506 packs.
Why was this product recalled? ▼
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 15, 2019. Severity: Critical. Recall number: D-1293-2019.
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