Apace KY LLC Recalls Amantadine HCl Capsules Due to Labeling Error
Apace KY LLC is recalling 1,483 cartons of Amantadine HCl Capsules because they were mislabeled and contain Cyclobenzaprine HCl tablets instead.
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, which typically involves minor labeling errors or low-risk contamination where adverse health consequences are unlikely or temporary. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Apace KY LLC is recalling 1,483 cartons of Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons. The product was manufactured for AvKARE Inc. The specific lot number is 16710, with an expiration date of 07/2018. The NDC number is 50268-0069-15.
The recall was initiated due to a labeling mix-up. Cartons labeled as Amantadine HCl 100 mg Capsules actually contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg. This is a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences.
The affected product was distributed in Kentucky (KY). Patients and healthcare providers should check their inventory for this specific lot and stop using the product if found. They should contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
- Manufacturer
- Apace KY LLC
- Category
- Drug — Prescription Medication
- Affected units
- 1,483
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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