Recalls / Class I
Class ID-1206-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
- Brand name
- Hydrochlorothiazide
- Generic name
- Hydrochlorothiazide
- Active ingredient
- Hydrochlorothiazide
- Route
- Oral
- NDCs
- 16729-182, 16729-183, 16729-184
- FDA application
- ANDA202556
- Affected lot / code info
- Lot: PW05264, Exp. 11/2019
Why it was recalled
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 46,632 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2018-08-21
- FDA classified
- 2018-09-21
- Posted by FDA
- 2018-09-19
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1206-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.