ACETAMINOPHEN Recall D-0014-2023
Description: NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
ACETAMINOPHEN Recall D-0014-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0014-2023 |
| Event ID | 90983 |
| Brand | SINUS PRESSURE, PAIN AND COUGH |
| Generic Name | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL |
| Manufacturer | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL |
| Original Package? | 1 |
| Active Substance | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE |
| Drug Route | ORAL |
| Distribution | Nationwide |
| Quantity | 66,384 boxes of twenty tablets each |
| Recall Reason | Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg |
| Drug Classification | Class III |
| Drug Code Info | 20221026 |
| Product NDC | 0363-6171 |
| Product NUI | N0000193956 N0000008867 N0000009560 |
| Drug UPC | 0311917009476 |
| Pharma Class (PE) | Decreased Respiratory Secretion Viscosity [PE] |
| Pharma Class (EPC) | Expectorant [EPC] |
| Recall Initiation Date | 20221011 |
| Report Date | 20221026 |
| Classification Date | 20221018 |
| Address | 55 Arkay Dr Hauppauge, NY 11788-3707 United States |
| Recalling Firm | LNK International, Inc. |
| Initial Notification | |
| Unique Ingredient Identifier | 362O9ITL9D 9D2RTI9KYH |
| Drug Application Number | part341 |
| Structured Product Labeling (SPL ID) | e416d326-82a1-41e3-91d8-63b90864dd85 |
| Structured Product Labeling (SPL Set ID) | 97554f40-f9aa-4dbf-a6f2-de6197236ab4 |
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