Low FDA (Drugs)·D-0809-2016·Announced 2016-04-13

Bio-pharm Recalls Ranitidine Syrup Due to Elevated Impurity Levels

Bio-pharm, Inc. is recalling Ranitidine Syrup because routine stability testing detected elevated impurity levels.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which indicates the use of, or exposure to, the product is not likely to cause adverse health consequences.

Plain-English summary

Bio-pharm, Inc. is recalling Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, 16 fl oz bottles. The product was manufactured for Heritage Pharmaceuticals Inc. and is available by prescription only.

The recall was initiated because routine stability testing detected an elevated impurity result. The affected product includes 103,664 bottles distributed nationwide and in Puerto Rico.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternatives or disposal.

The recalled product

Product: Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Manufacturer: Bio-pharm, Inc.
Category: Drug — Oral Solution
Hazard: impurity
Affected units: 103,664

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot #s: 14G008
14G013
14G010
14G015
14G016
14G021
14G026
14G028
Exp. 01/2016
14K027
14K023
Exp. 04/2016
15B040
15B041
Exp. 08/2016
15E042
Exp. 11/2016
15F019
15F021
Exp. 12/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Bio-pharm, Inc.

See all →

Moderate
Bio-Pharm Recalls Acetaminophen Oral Suspension Due to Assay Failure
FDA (Drugs) · 2014-10-29

Same hazard · impurity