Agency classClass IIOur severity:Moderate FDA (Drugs)·D-500-2013·Announced 2013-06-05

Mylan Recalls Mislabelled Ropinirole Hydrochloride Tablets Due to Strength Error

Mylan Pharmaceuticals is recalling 3,048 bottles of Ropinirole hydrochloride tablets because 3 mg bottles were incorrectly labeled as 4 mg.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 and involves a labeling error regarding drug strength. Per the rubric, minor labeling errors and low-risk contamination fall under the Moderate severity category.

Plain-English summary

Mylan Pharmaceuticals, Inc. is recalling 3,048 bottles of Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottles (NDC 0378-5504-01). The recall was initiated because unopened bottles of Ropinirole USP 3 mg tablets were found to be incorrectly labeled as Ropinirole USP 4 mg tablets. The affected product is identified by Lot # ZRMB11004 and an expiration date of 09/13.

The product was distributed nationwide. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should check their inventory for bottles matching the specific lot number and expiration date listed above. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding the correct dosage of their medication.

The recalled product

Product: Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
Manufacturer: Mylan Pharmaceuticals Inc.
Category: Drug — Prescription Medication
Hazard: mis-labeling
Affected units: 3,048

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 (2)

Lot # ZRMB11004
Exp 09/13

Distribution

Distributed nationwide across the United States.

Same manufacturer · Mylan Pharmaceuticals Inc.

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