Bulletin

Ciprofloxacin Immediate-Release Tablets

22 January 2010

Products Affected - Description

Cipro Tablets, Schering
250 mg, 100 count, unit dose (NDC 00085-1758-02)
500 mg, 100 count (NDC 00085-1754-01)
500 mg, 100 count, unit dose (NDC 00085-1754-02)
750 mg, 50 count (NDC 00085-1756-01) - discontinued
750 mg, 100 count, unit dose (NDC 00085-1756-02) - discontinued

Ciprofloxacin Immediate-Release Tablets, Apotex
250 mg, 100 count (NDC 60505-1308-01)
500 mg, 100 count (NDC 60505-1309-01)
500 mg, 4500 count (NDC 60505-1309-07)
750 mg, 50 count (NDC 60505-1310-04)
750 mg, 100 count (NDC 60505-1310-01)

Ciprofloxacin Immediate-Release Tablets, Watson (formerly Cobalt)
250 mg, 100 count (NDC 16252-0514-01)

500 mg 100 count (NDC 16252-0515-01)
750 mg 50 count (NDC 16252-0516-05)

Ciprofloxacin Immediate-Release Tablets, Dr. Reddy’s
250 mg, 100 count (NDC 55111-0126-01)
250 mg, 500 count (NDC 55111-0126-05)
500 mg, 100 count (NDC 55111-0127-01)
500 mg, 500 count (NDC 55111-0127-05)
750 mg, 50 count (NDC 55111-0128-50)

Ciprofloxacin Immediate-Release Tablets, Major
250 mg, 100 count, unit dose (NDC 00904-5842-61)
500 mg, 100 count, unit dose (NDC 00904-5813-61)

Ciprofloxacin Immediate-Release Tablets, Marlex
500 mg, 100 count (NDC 10135-0475-01)

Ciprofloxacin Immediate-Release Tablets, Ranbaxy
250 mg, 100 count (NDC 63304-0709-01)
500 mg, 100 count (NDC 63304-0710-01)
750 mg, 100 count (NDC 63304-0711-01)
750 mg, 50 count (NDC 63304-0711-50)

Ciprofloxacin Immediate-Release Tablets, Teva
250 mg, 100 count (NDC 00172-5311-60)
250 mg, 100 count, unit dose (NDC 00172-5311-10)
500 mg, 100 count (NDC 00172-5312-60)
500 mg, 100 count, unit dose (NDC 00172-5312-10)
500 mg, 500 count (NDC 00172-5312-70)
750 mg, 100 count (NDC 00172-5313-60
750 mg, 100 count, unit dose (NDC 00172-5313-10

Ciprofloxacin Immediate-Release Tablets, UDL
250 mg, 100 count, unit dose (NDC 51079-0402-20)
500 mg, 100 count, unit dose (NDC 51079-0403-20)

250 mg, 100 count, unit dose (NDC 51079-0218-20) - discontinued
500 mg, 100 count, unit dose (NDC 51079-0233-20) - discontinued

Ciprofloxacin Immediate-Release Tablets, Westward
250 mg, 100 count (NDC 00143-9927-01)
500 mg, 100 count (NDC 00143-9928-01)
750 mg, 50 count (NDC 00143-9929-50)

Reason for the Shortage

Apotex has halted manufacturing due to an FDA audit.
Ranbaxy has an FDA import ban on several of their products manufactured in India.
Dr. Reddy’s states their shortage is due to supply and demand issues.
Major, Marlex, Schering, Teva, UDL, and Westward are unable to provide a reason for their shortage.
Cobalt was acquired by Watson and Watson will start shipping their products in January, 2010.

Estimated Resupply Dates

Schering has available ciprofloxacin immediate-release tablets 250 mg in the 100 count presentation (NDC 00085-1758-01). Schering has all their other Cipro tablets on back order and the company cannot estimate a release date. Cipro 750 mg presentations were discontinued in April, 2009.
Watson (formerly Cobalt) has all of their ciprofloxacin immediate-release tablets on back order. The company estimates a release date of mid-February, 2010 for the 250 mg tablets, mid-March, 2010 for the 500 mg tablets, and mid-April, 2010 for the 750 mg tablets.
Teva has all ciprofloxacin presentations temporarily unavailable.
UDL has ciprofloxacin tablets 250 mg and 500 mg 100 count unit dose presentations on back order and the company cannot estimate a release date. UDL has discontinued their other 250 mg and 500 mg unit dose presentations.
Dr. Reddy’s has their ciprofloxacin immediate-release tablets on intermittent back order. The company is releasing product as it becomes available.
Westward has all ciprofloxacin tablets on back order. The company estimates a release of February, 2010, however the presentations will be on allocation.
Major has their ciprofloxacin immediate-release tablets on back order and the company cannot estimate a release date.
Marlex has their ciprofloxacin immediate-release tablets in 500 mg 100 count on back order and the company cannot estimate a release date.
Apotex and Ranbaxy have their ciprofloxacin immediate-release tablets on back order and the companies cannot estimate a release date.

Related Shortages

Aztreonam Injection
Carbenicillin Indanyl Capsules— No Longer Available
Cefaclor
Cefazolin Injection— Resolved
Cefepime Injection— Resolved
Cefotetan Disodium— Resolved
Cefotetan Injection— Resolved
Cefoxitin Injection— Resolved
Ceftizoxime Injection— Resolved
Cefuroxime Injection— Resolved
Doxycycline Hyclate Injection
Erythromycin Lactobionate Injection
Erythromycin Ophthalmic Ointment
Imipenem and Cilastatin Injection— Resolved
Kanamycin— Resolved
Kanamycin Sulfate Injection
Loracarbef Oral Tablets and Suspension— No Longer Available
Minocycline Injection— No Longer Available
Nafcillin Injection— Resolved
Oxacillin Injection— Resolved
Penicillin G Benzathine Injection— Resolved
Penicillin G Procaine Suspension for Injection— Resolved
Piperacillin and Tazobactam Injection— Resolved
Polymyxin B Injection— Resolved
Ticarcillin and Clavulanate Injection— Resolved
Tigecycline Injection— Resolved
Tobramycin Powder for Injection
Vancomycin Hydrochloride Injection

Updated

January 22, 2010; January 8, 2010; December 21, 2009; December 10, 2009; December 8, 2009; November 5, 2009; October 15, 2009, University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.

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