Unichem Recalls Hydrochlorothiazide Tablets Due to Foreign Tablet Presence
Unichem Pharmaceuticals is recalling 4,776 bottles of hydrochlorothiazide 25 mg tablets because a pharmacist found a clopidogrel tablet in one bottle.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign tablet (clopidogrel) in a hydrochlorothiazide bottle, which poses a risk of harm through incorrect medication administration. No illnesses or injuries are reported in the source text, placing this in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Unichem Pharmaceuticals (USA), Inc. is recalling 4,776 bottles of Hydrochlorothiazide Tablet USP 25 mg, 1000-count, Rx Only. The product is manufactured by Unichem Laboratories Ltd. in India and marketed by Unichem Pharmaceuticals (USA), Inc. in Rochelle Park, NJ. The specific lot number is GHYL15028 with an expiration date of April 2018.
The recall was initiated after a pharmacist discovered a clopidogrel tablet inside a 1000-count bottle of hydrochlorothiazide 25 mg tablets. This constitutes a foreign tablet hazard, as the presence of an unintended medication in a prescription drug container poses a risk of incorrect dosing or unintended drug administration.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for bottles with NDC 29300-128-10, Lot # GHYL15028, and an expiration date of April 2018. If found, the product should be returned to the pharmacy or distributor for credit or replacement.
The recalled product
- Product
- HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE)
- Brand
- HYDROCHLOROTHIAZIDE
- Manufacturer
- Unichem Pharmaceuticals Usa Inc
- Category
- Drug — Prescription Drug
- Affected units
- 4,776
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 #: GHYL15028
- Exp April 2018
UPCs (2)
- 0329300129014
- 0329300128017
Distribution
Distributed nationwide across the United States.
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