Apace Recalls Enalapril Maleate Tablets Due to Illegible Labeling
Apace KY LLC is recalling 81,516 bottles of Enalapril Maleate 5mg tablets because some labels have incomplete NDC numbers and missing strength information.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging and labeling issues (illegible text) rather than a product defect or contamination.
Plain-English summary
Apace KY LLC is voluntarily recalling 81,516 bottles of Enalapril Maleate Tablet, USP 5mg (NDC 15338-211-30). The recall was initiated because some bottle labels have incomplete NDC numbers and missing strength information, rendering the labeling illegible.
The affected product is a prescription medication distributed nationwide. The specific lot number is DL11600, with an expiration date of 06/13.
Consumers and healthcare providers should check their inventory for this specific NDC and lot number. If the product is found, it should be returned to the pharmacy or distributor for credit. Patients should consult their healthcare provider regarding alternative medication options if necessary.
The recalled product
- Product
- Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
- Manufacturer
- Apace KY LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 81,516
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 (1)
- Lot: DL11600 Exp Date: 06/13
Distribution
Distributed nationwide across the United States.
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