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.
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 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
- 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.
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