Why it was 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.
Product description
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,
Lot numbers, UPCs & expiration codes
Lot 3L20, Exp. 11/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0028-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 16, 2014
- FDA report date
- Oct 29, 2014
- Quantity
- 35,739 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bio-pharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0028-2015, exactly as published.
Show all FDA fields
- City
- Levittown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68847
- Address
- 2091 Hartel Ave
- Code information
- Lot 3L20, Exp. 11/15
- Postal code
- 19057-4506
- Report date
- Oct 29, 2014
- Product type
- Drugs
- Recall number
- D-0028-2015
- Classification
- Class II
- Recalling firm
- Bio-pharm, Inc.
- Product quantity
- 35,739 bottles
- Termination date
- Aug 10, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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,
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 16, 2014
- Initial firm notification
- Telephone
- Center classification date
- Oct 17, 2014