Sodium Bicarbonate Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling 1,013 sodium bicarbonate tablets that may be mislabeled as nicotine polacrilex lozenges.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of a patient taking a nicotine product instead of a sodium bicarbonate antacid.
Plain-English summary
Aidapak Services, LLC is recalling 1,013 tablets of SODIUM BICARBONATE, 650 mg, Over The Counter (NDC 64980018210). The recall is due to a labeling error where the product may be mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg (NDC 00135051001). The affected product has the pedigree W002970 and an expiration date of 6/11/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers should check their medication cabinets for sodium bicarbonate tablets with the specified NDC and pedigree. If found, they should stop using the product and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- SODIUM BICARBONATE Tablet, 650 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980018210
- Manufacturer
- Aidapak Services, LLC
- Hazard
- Affected units
- 1,013
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- SODIUM BICARBONATE Tablet
- 650 mg has the following code Pedigree: W002970
- EXP: 6/11/2014.
Distribution
Part of a larger recall action
This product is one of 273 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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