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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0878-2022 |
Event ID | 90062 |
Brand | PHENOBARBITAL |
Generic Name | PHENOBARBITAL |
Manufacturer | PHENOBARBITAL |
Original Package? | 1 |
Active Substance | PHENOBARBITAL |
Drug Route | ORAL |
Distribution | TN only |
Quantity | 15,730 bottles |
Recall Reason | Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content |
Drug Classification | Class III |
Drug Code Info | 20220525 |
Product NDC | 69367-172 |
Recall Initiation Date | 20220414 |
Report Date | 20220525 |
Classification Date | 20220517 |
Address | 7333 Jack Newell Blvd N Ste 100 Fort Worth, TX 76118-7151 United States |
Recalling Firm | Monarch PCM, LLC |
Initial Notification | Letter |
Unique Ingredient Identifier | YQE403BP4D |
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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