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
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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, 25 mg (1/2 of 50 mg), NDC 57664037708, Pedigree: AD60272_92, EXP: 5/22/2014.
LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00591024001.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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…
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.