Recalls / Class I
Class ID-1293-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Mycophenolate Mofetil
- Generic name
- Mycophenolate Mofetil
- Active ingredient
- Mycophenolate Mofetil
- Route
- Intravenous
- NDC
- 42023-172
- FDA application
- ANDA203575
- Affected lot / code info
- AD812, exp 9/2020
Why it was recalled
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Recalling firm
- Firm
- Par Pharmaceutical, Inc.
- Manufacturer
- Endo USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, N/A, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 4506 packs
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2019-04-30
- FDA classified
- 2019-05-22
- Posted by FDA
- 2019-05-15
- Terminated
- 2023-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1293-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.