MD Custom Rx Recalls Diphenhydramine Solution Due to Incorrect Solvent
MD Custom Rx is recalling Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution because specific products were compounded with an incorrect solvent.
What this means for you
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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Brookfield Prescription Center Inc. dba MD Custom Rx is recalling Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottles. The recall is due to specific drug products being compounded with an incorrect solvent.
The affected products are prescription-only and were distributed in Wisconsin. The specific lot number is 05012014@36 with a beyond use date of 05/15/14.
Consumers should check their medication for the specific lot number and beyond use date listed above. If the product matches the recall details, they should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
- Category
- Drug — Compounded Prescription
- Hazard
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 (1)
- Lot # / Beyond Use Date: 05012014@36 / 05/15/14
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 recalled by Brookfield Prescription Center Inc. dba MD Custom Rx 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.
See all 6 products in this recall →Related recalls
Same manufacturer · Brookfield Prescription Center Inc. dba MD Custom Rx
See all →- ModerateMometasone Irrigation Solution Recalled for Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateMD Custom Rx Recalls HCG Drops Due to Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateFDA Recalls HCG Tablets Compounded With Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateMD Custom Rx Recalls HCG and Methylcobalamin Drops Due to Incorrect Solvent
FDA (Drugs) · 2014-07-09
- ModerateMD Custom Rx Recalls HCG Drops Due to Incorrect Solvent
FDA (Drugs) · 2014-07-09
Same hazard · incorrect excipient
See all →- ModerateTadalafil Tablets Recalled for Incorrect Product Formulation
FDA (Drugs) · 2021-11-17
- ModerateQuVa Pharma Recalls Norepinephrine Injection Bags Due to Incorrect Excipient
FDA (Drugs) · 2018-12-19
- LowJubilant Cadista Recalls Valsartan Tablets Due to Potential Excipient Error
FDA (Drugs) · 2018-08-29
- LowJubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade
FDA (Drugs) · 2018-08-29
- ModerateJubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade
FDA (Drugs) · 2018-08-29