Why it was recalled
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0983-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2015
- FDA report date
- May 13, 2015
- Quantity
- 32,893 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Romark Laboratories, L.C.
Original FDA data
Every field from FDA enforcement report D-0983-2015, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 70914
- Address
- 3000 Bayport Dr Ste 200
- Code information
- Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.
- Postal code
- 33607-8416
- Report date
- May 13, 2015
- Product type
- Drugs
- Recall number
- D-0983-2015
- Classification
- Class II
- Recalling firm
- Romark Laboratories, L.C.
- Product quantity
- 32,893 bottles
- Termination date
- Oct 25, 2016
- Reason for recall
- Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 24, 2015
- Initial firm notification
- Letter
- Center classification date
- May 4, 2015