Reported May 25, 2022 · Terminated
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card,…
American Health Packaging
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: American Health Packaging · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
Nitrofurantoin CapsulesUSP (Monohydrate/Macrocrystals)100 mg100 Capsules (10 x 10)10-count blisters per card10 cards per cartonUnit Dose NDC 68084-446-11Rx Only
- Distributed byAmerican Health Packaging, Columbus, Ohio 43217
- NDC68084-446-01
- Lot codes and dates
Lot # 1003829Exp date 1/31/23
- Amount recalled
- 1603 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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