Drug Enforcement D-0365-2024

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Status

Ongoing

Classification

Class III

Report Date

March 13, 2024

Termination Date

—

Product Information

Product description
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
Product quantity
11,750 bottles
Reason for recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the U.S. and Puerto Rico

Location & Firm

Recalling firm
Contract Pharmaceuticals Limited Canada
Address
7600 East Danbro Cres

Canada
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0365-2024
Event ID
94066
Recall initiation date
February 20, 2024
Center classification date
March 1, 2024
Code info
Lot #: 119874; Exp 06/30/2025
More code info
—