Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
Affected NDC
55910-0092-79
Compare with the code on your package — it is the most precise check available.
Drug: Ranitidine Category: Heartburn & Stomach Medication
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55910-092-79
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0166-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
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 AuroMedics Pharma LLC
All 2019 recalls
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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