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Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Lack of assurance of sterility
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Presence of Foreign Tablets/Capsules
Labeling: Incorrect or Missing Package Insert
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Failed Dissolution Specifications
Nature's Power Solutions Acidophilus Blend due to undeclared milk allergen.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.