Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup
Aidapak Services is recalling 18,282 Cholecalciferol capsules because they may have been mislabeled as other drugs, including Doxycycline and Lamotrigine.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of patients taking incorrect medications.
Plain-English summary
Aidapak Services, LLC is recalling 18,282 units of Cholecalciferol, Capsule, 2000 units (NDC 00536379001). The recall was initiated due to a labeling error where the product may have been mislabeled as other medications, including Doxycycline Hyclate, Vitamin B Complex Prolonged Release, and Lamotrigine.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers specific pedigree codes and expiration dates ranging from May 1, 2014, to June 27, 2014.
Consumers should check their medication labels and discontinue use if the product matches the recalled description. They should contact their healthcare provider or pharmacist for guidance on appropriate alternatives.
The recalled product
- Product
- CHOLECALCIFEROL, Capsule, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536379001.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 18,282
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 (20)
- CHOLECALCIFEROL
- Capsule
- 2000 units has the following codes: Pedigree: AD30028_7
- EXP: 5/8/2014
- Pedigree: AD60240_4
- EXP: 5/22/2014
- Pedigree: ADWA00002136
- EXP: 5/31/2014
- Pedigree: W002666
- EXP: 6/5/2014
- Pedigree: W003016
- EXP: 6/12/2014
- Pedigree: W003017
- Pedigree: W003712
- EXP: 6/26/2014
- Pedigree: W003713
- Pedigree: W003828
- EXP: 6/27/2014
- Pedigree: AD21846_4
- EXP: 5/1/2014
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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