Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine 150 mg tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Cause type: Nitrosamine impurity
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. All nitrosamine impurity recalls.
What was recalled
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Affected NDC
37808-0196-04
Compare with the code on your package — it is the most precise check available.
Drug: Ranitidine Category: Heartburn & Stomach Medication
- Recalling firm
- AAA Pharmaceutical, Inc.
- NDC code
- 37808-196-04
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0646-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ranitidine recalls
See all
Class II · Moderate risk
Ranitidine 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Hydrochloride
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
ranitidine hydrochloride
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Other recalls by AAA Pharmaceutical, Inc.
All 2019 recalls
Class III · Low risk
Discount Drug Mart
Labeling: Incorrect or Missing Lot and/or Expiration date.
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class III · Low risk
Smart Sense Regular Strength Aspirin Tablets
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
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