Drug Enforcement D-0152-2024

CGMP Deviations: Stability data does not support expiry date.

Status

Ongoing

Classification

Class II

Report Date

December 27, 2023

Termination Date

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Product Information

Product description
Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
Product quantity
3,396 bottles
Reason for recall
CGMP Deviations: Stability data does not support expiry date.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
NJ

Location & Firm

Recalling firm
Private Label Partners, Inc.
Address
551 N Fairview St, N/A

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

Codes & Dates

Recall number
D-0152-2024
Event ID
93616
Recall initiation date
December 13, 2023
Center classification date
December 19, 2023
Code info
Lot #220551, Exp: 2/28/2025
More code info
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