CLASS III Drug recall · Reported 25 Jul 2012 · FDA Enforcement Report
Ciprofloxacin Tablets, USP, 500 mg recalled by Pack Pharmaceuticals
Pack Pharmaceuticals is recalling Ciprofloxacin Tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 9 Mar 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1422-2012
- FDA event ID
- 51880
- Recalling firm
- Pack Pharmaceuticals, Buffalo Grove, IL
- Brand
- Ciprofloxacin
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Mar 2012
- FDA classified
- 19 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Antibiotics
Timeline
| 9 Mar 2012 | Recall initiated by company | |
| 19 Jul 2012 | Classified by FDA | +132 days |
| 25 Jul 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Which lots are affected?
Lot #: : PUB1040, Exp 08/2015
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pack Pharmaceuticals
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals | Pack Pharmaceuticals | Potency & Assay | Nationwide |
Other Ciprofloxacin recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin ophthalmic solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl) recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |