Recalls of antihistamines, decongestants and nasal sprays.
320 recalls in this category, newest first.
Reason Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177…
Reason Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree…
Reason Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC…
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Reason Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination…
Reason Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Reason Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Reason Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
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