Accord Recalls Hydrochlorothiazide Tablets Due to Product Mix-Up
Accord Healthcare is recalling Hydrochlorothiazide 12.5 mg tablets because a customer complaint found Spironolactone 25 mg tablets in the bottles.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Accord Healthcare, Inc. is recalling 46,632 bottles of Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count. The recall was initiated after a customer complaint reported that a sealed bottle labeled as Hydrochlorothiazide 12.5 mg contained only Spironolactone Tablets USP 25 mg.
The affected product is identified by Lot PW05264 with an expiration date of 11/2019. The product was distributed nationwide in the USA and Puerto Rico. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The product is a prescription medication, and patients should not switch medications or adjust dosages without professional medical advice.
The recalled product
- Product
- HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE)
- Brand
- HYDROCHLOROTHIAZIDE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 46,632
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: PW05264
- Exp. 11/2019
Distribution
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