Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine Syrup
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Affected NDC
0603-9418-58
Compare with the code on your package — it is the most precise check available.
Drug: Ranitidine Category: Heartburn & Stomach Medication
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0162-2016 · 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. 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 Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
All 2015 recalls
Class III · Low risk
Hydrocortisone Lotion
Superpotent Drug: above specification for the assay.
Class III · Low risk
Dexamethasone Elixir
Failed Impurities/ Degradation Specifications
Class III · Low risk
Temazepam Capsules USP
Failed Stability Specifications
Class II · Moderate risk
Hydrochlorothiazide Capsules
Presence of Particulate Matter.
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