Class II · Moderate risk
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
FDA Drug Recalls
1,563 recalls, newest first
Class II · Moderate risk
CVS Health Children's Mucus Relief Chest Congestion Plus Cough…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Losartan Potassium Tablets USP 25 mg 30 count bottle NDC…
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class I · High risk
Mycophenolate Mofetil for Injection
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class II · Moderate risk
Losartan Potassium Tab. USP 50mg
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk
Ketorolac Tromethamine Injection
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Class II · Moderate risk
Losartan Potassium 100 mg
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Class III · Low risk
Relpax (eletriptan HBr)
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
Class II · Moderate risk
HYDROmorphone 20 mg/100 mL Injectable Solution
Sub-potency
Class III · Low risk
Dermoplast Anesthetic PAIN & ITCH
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class III · Low risk
Dermoplast Anesthetic PAIN & ITCH
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class II · Moderate risk
Revonto (dantrolene sodium for injection)
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Class II · Moderate risk
Carvedilol Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class II · Moderate risk
Acyclovir Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class I · High risk
Titanium 4000
Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Class III · Low risk
Fentanyl Citrate Injection
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Class II · Moderate risk
Unison Hand Care Products
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Antibacterial Hand Soap
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk
Sani-Guard-SF Waterless Foam Hand Sanitizer
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.