Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by…
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Yes — there is an active recall. 326 ongoing FDA recalls mention Chloride (1,994 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Failed Dissolution Specifications
Reason Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Reason Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.
Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.
Reason Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal…
Reason Failed Dissolution Specifications
Reason CGMP Deviations
Reason Subpotency: product assayed and found OOS for cyproheptadine
Reason Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it…
Reason Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250…
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Presence of Particulate Matter: Cardboard
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Reason Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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