Romark Recalls Alinia Powder for Oral Suspension Due to Stability Failure
Romark Laboratories is recalling specific lots of Alinia (nitazoxanide) powder for oral suspension because the product failed to meet long-term stability specifications for viscosity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a failure in stability specifications (viscosity). Per the rubric, this falls under 'Minor labeling errors, low-risk contamination, voluntary precautionary recalls' or similar non-critical quality issues where no immediate serious injury is reported.
Plain-English summary
Romark Laboratories, L.C. is recalling specific lots of Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. The recall involves 32,893 bottles distributed nationwide. The affected lots are MTEW1721, MTCW21281, and MTCW21291 (Exp 09/2016); MTEW5791 (Exp 12/2016); and MTEW5801 (Exp 01/2017).
The recall was initiated because the product failed to meet the 12-month long-term stability specification for viscosity. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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
- Manufacturer
- Romark Laboratories, L.C.
- Category
- Drug — Antiparasitic
- Hazard
- Affected units
- 32,893
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: MTEW1721
- MTCW21281
- MTCW21291
- Exp 09/2016
- Lot #: MTEW5791
- Exp 12/2016
- Lot #: MTEW5801
- Exp 01/2017.
Distribution
Distributed nationwide across the United States.
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