PlainRecalls
FDA Drug Low Class III Terminated

Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284

Reported: April 26, 2017 Initiated: January 5, 2017 #D-0674-2017

Product Description

Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284

Reason for Recall

Subpotent

Details

Recalling Firm
InnovaGel
Units Affected
Approximately 7,920,177 capsules
Distribution
NY only
Location
Miami, FL

Frequently Asked Questions

What product was recalled?
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284. Recalled by InnovaGel. Units affected: Approximately 7,920,177 capsules.
Why was this product recalled?
Subpotent
Which agency issued this recall?
This recall was issued by the FDA Drug on April 26, 2017. Severity: Low. Recall number: D-0674-2017.