PlainRecordsFDA · Drug recall
Ciprofloxacin in Dextrose (5%) Injection… and 3 more products
- Date
- April 5, 2017
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Claris Lifesciences Inc
- Reason
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Distribution pattern
- Nationwide
4 products in this recall
Ciprofloxacin in Dextrose (5%) Injection…
- Product
- Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
- Quantity
- 18,360 units (765 cartons x 24 bags)
- Codes and lots
- Lot #: A051288, Exp. Sep 2017
- Recall started
- March 10, 2017
- Recall number
- D-0613-2017
Fluconazole Injection…
- Product
- Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
- Quantity
- 18,096 units (3016 cartons x 6 bags)
- Codes and lots
- Lot #: A051052, Exp. Aug 2017
- Recall started
- March 10, 2017
- Recall number
- D-0614-2017
Levofloxacin Injection in 5% Dextrose…
- Product
- Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
- Quantity
- 24,456 units (1019 cartons x 24 bags)
- Codes and lots
- Lot #: A060040, Exp. Dec 2017
- Recall started
- March 10, 2017
- Recall number
- D-0615-2017
Metronidazole Injection…
- Product
- Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
- Quantity
- 72072 units
- Codes and lots
- Lot #: A060205; A060209, Exp.Jan 2018
- Recall started
- March 10, 2017
- Recall number
- D-0616-2017
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0613-2017, D-0614-2017, D-0615-2017, D-0616-2017. The agency record governs; check it and the company before acting.