Bethanechol Chloride suspension recalled due to insanitary manufacturing conditions
Wedgewood Village Pharmacy is recalling Bethanechol Chloride 1mg/ml suspension (lot 000-03715131) due to insanitary conditions and lack of processing controls observed during an FDA inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II drug recall based on observed insanitary conditions and lack of processing controls in manufacturing. No illnesses, injuries, or confirmed contamination have been reported, and the recall is precautionary in nature.
Plain-English summary
Wedgewood Village Pharmacy, LLC is recalling Bethanechol Chloride 1mg/ml, 80 ml suspension bottles in Banana/Strawberry flavors due to insanitary conditions and lack of processing controls observed during a recent FDA inspection. The affected product is distributed nationwide in the United States.
The medication was manufactured under conditions that did not meet FDA standards for processing controls and sanitation. Bethanechol Chloride is used to treat urinary retention and other medical conditions.
Consumers should not use the affected medication. If you have received this product, contact Wedgewood Village Pharmacy, LLC at 405 Heron Dr. Ste 200, Swedesboro, NJ 08085 for further instructions. If you have used this product and have health concerns, consult your healthcare provider.
The recalled product
- Product
- Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085
- Manufacturer
- Wedgewood Village Pharmacy, LLC
- Category
- Drug — Compounded Suspension
- Hazard
- Affected units
- 1
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 (2)
- Lot #: 000-03715131
- Exp Date: 07/19/22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Wedgewood Village Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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