Status
Terminated
Drug Enforcement D-1422-2012
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Classification
Class III
Report Date
July 25, 2012
Termination Date
July 19, 2012
Product Information
- Product description
- 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.
- Product quantity
- 4,848 bottles
- Reason for recall
- Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Pack Pharmaceuticals
- Address
-
1110 W Lake Cook Rd, Ste 301
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1422-2012
- Event ID
- 51880
- Recall initiation date
- March 9, 2012
- Center classification date
- July 19, 2012
- Code info
- Lot #: : PUB1040, Exp 08/2015
- More code info
- —