Class II · Moderate risk
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
BusPIRone Hydrochloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurity /Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Affected NDC
49884-0725-01
Compare with the code on your package — it is the most precise check available.
Drug: Iron
- Recalling firm
- Par Pharmaceutical Inc.
- NDC code
- 49884-725-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1542-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iron recalls
See all
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Ferrous Sulfate Iron Supplement Drops
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Par Pharmaceutical Inc.
All 2020 recalls
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.
Class I · High risk
Mycophenolate Mofetil for Injection
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
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