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

FDA recall notice · announced April 26, 2017 · Innovagel

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: NY only
Lot/code information: Batch #: 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018.
Quantity: Approximately 7,920,177 capsules
Status: Terminated
Products in this recall event:
- Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284 (D-0675-2017)
- 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 (D-0674-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.