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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- 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
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