Class III · Low risk
Ranitidine Syrup
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Alinia (nitazoxanide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
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
Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607
- Recalling firm
- Romark Laboratories, L.C.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0983-2015 · 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 stability / shelf life recalls from 2015
All stability / shelf life recalls
Class II · Moderate risk
HEPARIN Sodium in 0.45% Sodium Chloride
Stability Data Does Not Support Expiry
Class II · Moderate risk
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE
Stability Data Does Not Support Expiry
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
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