Western Drug Recalls Benadryl Injection Due to Sterility Concerns
Western Drug is recalling Benadryl 50mg/2mL Pres-Free Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric.
Plain-English summary
Western Drug Inc. is recalling Benadryl 50mg/2mL Pres-Free Injection, a prescription medication. The recall is being conducted because the product lacks assurance of sterility.
The recall includes all lots of the product. The medication was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injection
- 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 (1)
- all lots
Distribution
Part of a larger recall action
This product is one of 91 recalled by Western Drug 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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