Reported Feb 14, 2024 · Ongoing
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by:…
Amerisource Health Services LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amerisource Health Services LLC · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only
- Distributed byAmerican Health Packaging, Columbus, Ohio 43217
- NDC Carton68084-447-01
- NDC Unit Dose68084-447-11
- Lot codes and dates
Lot #: 1012275Exp 02/28/2025
- Amount recalled
- 2,850 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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