Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62986_1, EXP: 5/23/2014; LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD21790_25, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 100
LACTOBACILLUS Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980012950
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.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mislabeled as the following drug: REPAGLINIDE…
Reason Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760…
Reason Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360…
Reason Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC…
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