Ciprofloxacin Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Recall notice
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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Source Page by GovInfoNow · govinfonow.com/recall/46602-mylan-pharmaceuticals-inc-recalls-ciprofloxacin-tablets-usp-500-mg-100 · Recall date September 13, 2013 · FDA enforcement record: FDA #D-66403-011
Cite this page
“Ciprofloxacin Tablets.” GovInfoNow, recall dated September 13, 2013. https://govinfonow.com/recall/46602-mylan-pharmaceuticals-inc-recalls-ciprofloxacin-tablets-usp-500-mg-100. Based on FDA recall #D-66403-011 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-66403-011%22&limit=1).
How to tell if you have this one
- Brand
Mylan Pharmaceuticals Inc.- Category
Drug
All 12 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-66403-001 | Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 3037907, 3040106; b) 3037907, 3040106, 3044357 | 37,752 bottles |
| D-66403-002 | Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01; Lot #: 2003156, 2003157, 2003155, 3043491 | 4,722 bottles |
| D-66403-003 | Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 2003194, 2003195; b) 2003193 | 28,140 bottles |
| D-66403-004 | Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01; Lot #: 3032075, 3032076 | 521 bottles |
| D-66403-005 | Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot s: a) 3036490, 3036491, 3036492, 3039874; b) 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683 | 167,866 bottles |
| D-66403-006 | Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 2003159, 2003160, 2003161, 3043492; b) 2003158, 2003159, 3043492 | 30,878 bottles |
| D-66403-007 | Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 2003169, 2003170, 2003171, 2003172, 2003173, 3043493; b) 2003168, 2003169, 3043493 | 60,506 bottles |
| D-66403-008 | Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01; Lot #: 2003184, 2003185, 2003186, 3043495 | 11,701 bottles |
| D-66403-009 | Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***; Lot #: a) 2003177, 2003178, 2003179, 2003180, 3043496; b) 2003176, 2003177, 3043496 | 42,174 bottles |
| D-66403-010 | Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01; Lot #: 2003188, 2003189, 2003190, 2003191, 3043498 | 23,356 bottles |
| D-66403-011 | Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01; Lot #: 2002732, 2002733, 2002734, 2002735, 2002736, 2002737, 2002738, 2002739, 2002740, 2002741, 2002742, 2002743, 2002744, 2002745, 3030000, 3030001, 3030002, 3030003, 3030004, 3030005, 3030006, 3030016, 3030017, 3030018, 3030216, 3030217, 3030218, 3030219, 3030220, 3030221, 3030222, 3030223, 3030224, 3030225, 3030226, 3030227, 3030228, 3030229, 3030238, 3030351, 3030352, 3030354, 3030355, 3030356, 3030357, 3030358, 3031790, 3031792, 3031793, 3031794, 3031795, 3031796, 3031797, 3031798, 3032035, 3032036, 3032037, 3032038, 3032039, 3032040, 3032041, 3032042, 3032043, 3032044, 3032045, 3032046 | 941,270 bottles |
| D-66403-012 | Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.; Lot #: a) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525 | 101,450 bottles |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-66403-011 (September 13, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-66403-011 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.