Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL recall — FDA D-0108-2018
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Overview of recall records associated with Teva Pharmaceuticals USA, including dates, categories and classifications where available.
Classification mix: Class II: 120, Class III: 23, Class I: 4.
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Microbial Contamination of Non-Sterile Products
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Subpotency: due to a low, out of specification test result for assay during stability testing.
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Failed Dissolution Specifications: OOS result during stability testing
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
This page summarizes recall records in which the official source identifies Teva Pharmaceuticals USA as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.