Drug Enforcement D-0427-2024

cGMP Diviations

Status

Terminated

Classification

Class II

Report Date

April 3, 2024

Termination Date

September 9, 2024

Product Information

Product description
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
Product quantity
17,280 paper cartons
Reason for recall
cGMP Diviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Apothecus Pharmaceutical Corp.
Address
485 S Broadway Ste 27, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0427-2024
Event ID
94277
Recall initiation date
March 21, 2024
Center classification date
March 28, 2024
Code info
Lot # 1G008A/1G00804722, Exp 07/31/25
More code info
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