cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Other Drugs
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CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
cGMP deviations
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
ULTRAtab Laboratories
CGMP Deviations
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
ULTRAtab Laboratories
CGMP Deviations
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
ULTRAtab Laboratories
CGMP Deviations
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
ULTRAtab Laboratories
CGMP Deviations