Prescription and over-the-counter medications
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
West-ward Pharmaceutical
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Physicians Total Care
Subpotent; 15 month stability (by mfr)
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Fresenius Kabi USA LLC (FK USA)
Labeling: Missing label
CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
A B Nutrition
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
AstraZeneca
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
AstraZeneca
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.