Class II · Moderate risk
Theraflu Sugar-Free Nighttime Severe Cold & Cough
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Allergy & Cold Medication Recalls
Recalls of antihistamines, decongestants and nasal sprays.
314 recalls in this category, newest first.
Class II · Moderate risk
Theraflu MAX-D Severe Cold & Flu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu Severe Cold & Cough powder packets containing Daytime formula
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Diphenhydramine 50 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
HCG Nasal Spray
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Pure-Aid Allergy Relief
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Class III · Low risk
4 way Nasal Decongestant Menthol Nasal Spray
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
4 way Nasal Decongestant Fast Acting Nasal Spray
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class II · Moderate risk
Brompheniramine/Pseudoephedrine Dm
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Class II · Moderate risk
12-Hour Sinus
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
Children's Cetirizine HCl Chewable Tablets 5 mg
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Class II · Moderate risk
Diphenhydramine 25mg/Ml Injectable 90 Ml
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 FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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