Class I - Dangerous
Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Class I - Dangerous
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Class I - Dangerous
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class I - Dangerous
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Class I - Dangerous
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Class I - Dangerous
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class I - Dangerous
Microbial Contamination of Non Sterile Product; mold
Class I - Dangerous
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Class I - Dangerous
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Class I - Dangerous
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Class I - Dangerous
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
Galderma Laboratories, L.P.
Class I - Dangerous
Subpotent; fluocinolone acetonide.
Class I - Dangerous
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Class I - Dangerous
Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
Misbranded
Class I - Dangerous
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class I - Dangerous
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class I - Dangerous
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class I - Dangerous
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.