Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160… — Class II drug recall D-0028-2015
Terminated recall by Bio-pharm, Inc., reported 2014-10-29, distributed nationwide. Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 16
| Recall number | D-0028-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-pharm, Inc., Levittown, PA, United States |
| Recall initiated | 2014-07-16 |
| Classified | 2014-10-17 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Quantity | 35,739 bottles |
| Reason classes | potency |
| NDC | 00536-3606-96, 00904-6308-20 |
| Lot numbers | 11/15, 3L20 |
Product
Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,
Reason for recall
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0028-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.