Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection.
1,002 FDA drug recalls with this cause, newest first.
These recalls involve bacteria, mold, yeast or other microorganisms actually found in the finished product. This overlaps with sterility issues but is tracked separately because it usually points to a specific breakdown - a water system, an unsealed container, a contaminated raw material - rather than a general process failure. It carries a large share of Class I recalls: an organism such as Burkholderia cepacia or Pseudomonas in an eye drop, nasal spray or oral liquid can cause serious infection.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Well at Walgreens Regular Strength Antacid Liquid
Products failed the Antimicrobial Effectiveness Test.
Class II · Moderate risk
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit)
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class II · Moderate risk
Antacid Liquid Regular Strength Antacid & Anti-Gas
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Class II · Moderate risk
Erythromycin Pledgets USP
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Class II · Moderate risk
Entertainer's Secret Throat Relief
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Class II · Moderate risk
CVS pharmacy
Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.
Class II · Moderate risk
Xarelto (rivaroxaban)
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Class II · Moderate risk
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Class II · Moderate risk
Alcohol-Free Hand Sanitizer
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; complaints of mold in the overpouch
Class II · Moderate risk
Fagron
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk
Fagron
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk
Fagron
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class I · High risk
LOW Potassium Cardioplegia 792 mL
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
adenosine 90 mg in 0.9% sodium chloride/90 mL
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
del Nido Cardioplegia with Lidocaine 1052.8 ml
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
Pediatric Cardioplegia
Non Sterility; microbial contamination identified as Aspergillus species
Class II · Moderate risk
a) Walgreens Lansoprazole Delayed Release Capsules
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.
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