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.
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.
Lot numbers, UPCs & expiration codes
Lot #: : PUB1040, Exp 08/2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1422-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 9, 2012
- FDA report date
- Jul 25, 2012
- Quantity
- 4,848 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pack Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1422-2012, exactly as published.
Show all FDA fields
- City
- Buffalo Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 51880
- Address
- 1110 W Lake Cook Rd
- Address (line 2)
- Ste 301
- Code information
- Lot #: : PUB1040, Exp 08/2015
- Postal code
- 60089-1944
- Report date
- Jul 25, 2012
- Product type
- Drugs
- Recall number
- D-1422-2012
- Classification
- Class III
- Recalling firm
- Pack Pharmaceuticals
- Product quantity
- 4,848 bottles
- Termination date
- Jul 19, 2012
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 9, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2012