Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Mycophenolate Mofetil for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What 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
Drug: Phenol
- Recalling firm
- Par Pharmaceutical, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1293-2019 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenol recalls
See all
Class II · Moderate risk
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS
Class II · Moderate risk
Phenol 10%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Phenol
CGMP Deviations
Other recalls by Par Pharmaceutical, Inc.
All 2019 recalls
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class III · Low risk
PrediniSONE Tablets
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Class III · Low risk
Frovatriptan Succinate Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
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