Mylan Recalls Tolterodine Tartrate Tablets Due to Impurity Failures
Mylan Pharmaceuticals is recalling 9,225 bottles of Tolterodine Tartrate Tablets, 1 mg, because the product failed impurity specifications for lactol and total impurities.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 9,225 bottles of Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. The product is identified by NDC 0378-5445-91. The recall involves Lot # 2004069 and Lot # 2004070, both with an expiration date of 09/2014.
The recall was initiated because the product failed impurities and degradation specifications, specifically testing out of specification for lactol and total impurities. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or credit in accordance with standard recall procedures.
The recalled product
- Product
- Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 9,225
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 (4)
- Lot # 2004069
- Expiry: 09/2014
- Lot #: 2004070
- Expiry: 09/2014.
Distribution
Distributed nationwide across the United States.
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