Drug product

Cyclandelate 200 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

D-1059-2015

February 12, 2015

Class II

Product summary

Firm: Health Innovations Pharmacy, Inc
Event: Event 70656
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-1059-2015

Official wording

Reason: Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Code information: All lots

Distribution pattern: NC

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Stability Data does not Support Expiry
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility