Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1701-2020Class II

Spice (Jwh-018) Cc443

Carolina Liquid Chemistries / initiated 2020-02-10 / Terminated / root cause: labeling and UDI

Carolina Liquid Chemistries Corp began a recall of SPICE (JWH-018) CC443 on . FDA classified it as Class II and gives the reason as "Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1701-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Carolina Liquid Chemistries
Product
Spice (Jwh-018) Cc443
Product code
LDJ Enzyme Immunoassay, Cannabinoids
Reason for recall
Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
On 01/20/2020, Immediate Action Required notices were emailed to Laboratory Directors inquiring about the disposition of discontinued products; whether they had been used, if there was remaining inventory. Customers were asked to fill out and return the Immediate Action Required form. Customers were provided with the following contact information: 336-722-8910 and carolinachemistries.com
Distribution
U.S.: NY, AL, CA, LA
Product codes and lots
Lots: D1906, D1939

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1701-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1701-2020Class IITerminatedVoluntary: Firm initiated