Aidapak Recalls Lactobacillus GG Capsules Due to Labeling Mixup
Aidapak Services is recalling Lactobillus GG capsules because they may be mislabeled as other medications, including Tacrolimus.
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 and involves a potential mixup with Tacrolimus, an immunosuppressant, which poses a significant risk of serious injury if misused.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling 1,970 capsules of Lactobacillus GG, an over-the-counter product, due to a labeling mixup. The recall is classified as FDA Class II.
The affected capsules may be mislabeled as Vitamin B Complex W/C, Docusate Sodium, Vitamin B Complex with C/Folic Acid, or Tacrolimus. The recall involves specific pedigree codes and expiration dates ranging from May 13, 2014, to June 14, 2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers should check their medication labels and discontinue use if the product matches the recalled description.
The recalled product
- Product
- LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 1,970
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 (14)
- LACTOBACILLUS GG
- Capsule has the following codes Pedigree: AD39588_4
- EXP: 5/13/2014 Pedigree: AD65457_16
- EXP: 5/24/2014 Pedigree: AD70655_8
- EXP: 5/29/2014 Pedigree: AD73627_17
- EXP: 5/30/2014 Pedigree: W003051
- EXP: 6/12/2014 Pedigree: W003216
- EXP: 6/14/2014 Pedigree: AD42584_12
- EXP: 5/14/2014 Pedigree: AD46300_11
- EXP: 5/15/2014 Pedigree: W002968
- EXP: 6/11/2014 Pedigree: AD68019_1
- EXP: 5/28/2014 Pedigree: W003172
- EXP: 6/13/2014 Pedigree: W003173
- EXP: 6/13/2014
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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