Recalls / Class III
Class IIID-1422-2012
Product
Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.
- Brand name
- Ciprofloxacin
- Generic name
- Ciprofloxacin
- Active ingredient
- Ciprofloxacin Hydrochloride
- Route
- Oral
- NDCs
- 16571-411, 16571-412, 16571-413
- FDA application
- ANDA076639
- Affected lot / code info
- Lot #: : PUB1040, Exp 08/2015
Why it was recalled
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Recalling firm
- Firm
- Pack Pharmaceuticals
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1110 W Lake Cook Rd, Ste 301, Buffalo Grove, Illinois 60089-1944
Distribution
- Quantity
- 4,848 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-03-09
- FDA classified
- 2012-07-19
- Posted by FDA
- 2012-07-25
- Terminated
- 2012-07-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1422-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.