This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Class I - Dangerous
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Labeling: Not elsewhere classified: Mislabeling
Class I - Dangerous
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class I - Dangerous
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)