CLASS II Drug recall · Reported 29 Oct 2014 · FDA Enforcement Report
Rugby Children's Pain and Fever Acetaminophen Oral recalled by Bio-pharm
Bio-pharm is recalling Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/, Cherry Flavor, distributed nationwide in the US. The recall was initiated on 16 Jul 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0028-2015
- FDA event ID
- 68847
- Recalling firm
- Bio-pharm, Levittown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2014
- FDA classified
- 17 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 16 Jul 2014 | Recall initiated by company | |
| 17 Oct 2014 | Classified by FDA | +93 days |
| 29 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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,
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot 3L20, Exp. 11/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bio-pharm
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled | Bio-pharm | Potency & Assay | Nationwide |