Recalls / Class III
Class IIID-0273-2019
Product
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 NDC: 68064-446-11)
- Affected lot / code info
- Lot#: 180310, 180612, Exp 03/31/20
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."
Recalling firm
- Firm
- AMERICAN HEALTH PACKAGING
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 4508 blister packs
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-11-09
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-28
- Terminated
- 2020-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0273-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.