Reported Oct 11, 2023 · Terminated
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American…
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 Tablets (10 x 10) per carton, Rx Only
- Distributed byAmerican Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01
- Individual Dose NDC68084-447-11
- Lot codes and dates
Lot#: 1007002Exp 12/31/2023
- Amount recalled
- 3,344 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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