FDAFDA · Food and drugs·Recall number D-1036-2017
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
Published August 9, 2017 · Recall initiated: June 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Apace KY LLC
- Distributor
- KY
- Lot
- Lot: 16710, exp 07/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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