Cyclobenzaprine Tablets Recalled for Incorrect Amantadine Labeling
Apace KY LLC is recalling Cyclobenzaprine HCl 5 mg tablets because cartons were mislabeled as Amantadine HCl 100 mg capsules.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classifies this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential medication errors that could lead to significant injury.
Plain-English summary
Apace KY LLC is recalling Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons. The recall is due to a labeling error where cartons labeled as Amantadine HCl 100 mg Capsules actually contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg.
The affected product is identified by Lot 16710 with an expiration date of 07/2018. The product was distributed in Kentucky. The NDC for the product is 50268-0190-15.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The FDA classifies this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15
- Manufacturer
- Apace KY LLC
- Category
- Drug — Prescription Medication
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: 16710
- exp 07/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Apace KY LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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