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PHENOBARBITAL Recall D-0878-2022

Description: Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

PHENOBARBITAL Recall D-0878-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0878-2022
Event ID90062
Original Package?1
Drug RouteORAL
DistributionTN only
Quantity15,730 bottles
Recall ReasonDoes Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Drug ClassificationClass III
Drug Code Info20220525
Product NDC69367-172
Recall Initiation Date20220414
Report Date20220525
Classification Date20220517
Address7333 Jack Newell Blvd N Ste 100
Fort Worth, TX 76118-7151
United States
Recalling FirmMonarch PCM, LLC
Initial Notification Letter
Unique Ingredient IdentifierYQE403BP4D
Structured Product Labeling (SPL ID)bf0669e8-56d6-4723-8df5-575d6cc220d9
Structured Product Labeling (SPL Set ID)b22cec13-f480-4472-ba6a-f01b3c3ad8ee
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