Class II · Moderate risk
Regular Strength Zantac 150 mg Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Nitrosamine impurities (NDMA/NDEA)
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls.
568 FDA drug recalls with this cause, newest first.
Nitrosamine compounds such as NDMA, NDEA or NMBA are probable human carcinogens that can form during manufacturing or storage. Recalls here trace back to a nitrosamine found above the accepted limit - whether the report names the compound or simply calls it a 'carcinogenic impurity'. It is a newer category, driven by improved testing methods that can now detect impurities that were previously missed, and it is the chemistry behind the large valsartan, losartan and ranitidine (Zantac) recalls.
Class II · Moderate risk
Maximum Strength Zantac 150 mg Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Regular Strength Zantac 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx…
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx…
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Dr. Reddy's Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Dr. Reddy's Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Dr. Reddy's Ranitidine Capsules
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets 75 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Dr. Reddy's: Ranitidine Capsules 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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