Aidapak Recalls Lithium Carbonate ER Tablets Due to Labeling Errors
Aidapak Services is recalling Lithium Carbonate ER tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error (label mixup) rather than a contamination or structural defect, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Aidapak Services, LLC is recalling 1,899 tablets of Lithium Carbonate ER, 450 mg, prescription-only medication. The recall was initiated because the product may be potentially mislabeled as other drugs, including Hyoscyamine Sulfate SL, Lactobacillus Acidophilus, or Hydrocortisone.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected lots, ranging from May 1, 2014, to June 25, 2014.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree codes listed in the recall notice. If the product is found, it should be returned to the distributor or pharmacy for replacement or refund.
The recalled product
- Product
- LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,899
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 (10)
- LITHIUM CARBONATE ER
- Tablet
- 450 mg has the following codes: Pedigree: AD21790_28
- EXP: 5/1/2014 Pedigree: AD46265_10
- EXP: 5/15/2014 Pedigree: W002730
- EXP: 6/6/2014 Pedigree: W003681
- EXP: 6/25/2014 Pedigree: AD60272_25
- EXP: 5/22/2014 Pedigree: AD62796_1
- EXP: 5/22/2014 Pedigree: W003327
- EXP: 6/19/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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