Reported Nov 28, 2018 · Terminated
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource…
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 Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217
- NDC 68084-446-01 (Individual Dose NDC68064-446-11)
- Lot codes and dates
Lot#: 180310180612Exp 03/31/20
- Amount recalled
- 4508 blister packs
Where it was sold
- Nationwide
Why it was recalled
Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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