Recalls / Class II
Class IID-1036-2017
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
- Affected lot / code info
- Lot: 16710, exp 07/2018
Why it was recalled
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Recalling firm
- Firm
- Apace KY LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 12954 Fountain Run Rd, N/A, Fountain Run, Kentucky 42133-7914
Distribution
- Quantity
- N/A
- Distribution pattern
- KY
Timeline
- Recall initiated
- 2017-06-19
- FDA classified
- 2017-07-31
- Posted by FDA
- 2017-08-09
- Terminated
- 2018-05-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1036-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.