Class II · Moderate risk Ongoing
Vial Label: 8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility.
Omeprazole/Sodium Bicarbonate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003788, EXP: 6/27/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003870, EXP: 6/27/2014.
What was recalled
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-501-2014
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.
Other Bicarbonate recalls
See all
Class II · Moderate risk Ongoing
4.2% Sodium Bicarbonate Injection
Reason Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II · Moderate risk Ongoing
8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility
Class I · High risk Ongoing
SinuCleanse Soft Tip NETI POT Nasal Wash System
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk Ongoing
SinuCleanse Premixed SALINE PACKETS
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
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