Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC#…
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
21 FDA recalls mention Lorazepam. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lorazepam.
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Reason Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the…
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Reason Lack of Assurance of Sterility
Reason Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Reason Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Reason Labeling: Label Mixup: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: traMADol HCl, Tablet…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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