Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine various strengths in syringes
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Ranitidine various strengths in syringes
Drug: Ranitidine Category: Heartburn & Stomach Medication
- Recalling firm
- Walgreens Infusion Services
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0368-2015 · 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 Walgreens Infusion Services
All 2014 recalls
Class II · Moderate risk
3-in-1 TPN formula daily+overfill Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride/MVI injection 2000 mL Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride injection bag
Lack of Assurance of Sterility
Class II · Moderate risk
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL
Lack of Assurance of Sterility
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