methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603459321.
Check against the official notice below — it lists the full affected range.
AidaPak Services, LLC distributed approximately 299 tablets of methylPREDNISolone 4 mg that may have been mislabeled as Omeprazole/Sodium Bicarbonate 20 mg/110 mg capsules. The affected product has NDC 00603459321 and was distributed to patients in Arizona, California, Oregon, and Washington. The potentially mislabeled medication carried Pedigree AD42584_15 with an expiration date of 5/14/2014.
This labeling mixup creates a significant safety concern because patients expecting to receive an antacid medication could instead receive a corticosteroid with different dosing, administration, and potential side effects. The recall record does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as the following drug: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, NDC 11523726503, Pedigree: AD42584_15, EXP: 5/14/2014.
Reason for recall: Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as the following drug: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, NDC 11523726503, Pedigree: AD42584_15, EXP: 5/14/2014. Distribution: Repacked drugs were distributed in Arizona, California, Oregon, and Washington. Quantity: 299 Tablets Lot/code info: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as the following drug: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, NDC 11523726503, Pedigree: AD42584_15, EXP: 5/14/2014.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.