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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Pets & Animals/Pet Medications

Franck's Lab Inc., d.b.a. Franck's Compounding Lab: Sterile Veterinary Drugs Recalled for Potential Microorganism and Fungal Growth

Agency Publication Date: June 25, 2012
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Summary

Franck's Lab Inc. has recalled all sterile veterinary drugs, including various ophthalmic (eye) drops, ointments, oral suspensions, and medical devices, distributed between November 21, 2011, and May 21, 2012. Approximately 1,684 units are affected by this recall after FDA environmental sampling discovered microorganisms and fungal growth within the clean room where these sterile products were prepared. The contamination was found in the very environment intended to be sterile, posing a significant risk to animals treated with these medications.

Risk

The presence of microorganisms and fungi in a sterile compounding environment can lead to serious infections or other adverse health reactions in animals. If a contaminated product is used, especially in sensitive areas like the eyes or via injection, it can cause severe illness, permanent injury, or even death to the pet.

What You Should Do

  1. Check your veterinary medication packaging for the manufacturer name 'Franck's Lab Inc.' or 'Franck's Compounding Lab' and verify the prescription (RX) or reference (REX) numbers.
  2. Immediately identify if you have affected products such as Cyclosporine eye solutions, Chloramphenicol ointments, or Cyproheptadine suspensions with RX numbers like 0387911, 0401548, or 0399876.
  3. Stop using any recalled medication or medical device immediately and consult with your veterinarian to find a safe alternative treatment for your animal.
  4. Contact your veterinarian or pharmacist for guidance on how to safely return any unused product and to discuss potential refunds or replacements.
  5. Return any unused or remaining recalled product to the veterinary clinic or pharmacy where it was originally purchased.
  6. Monitor your pet for any signs of infection, irritation, or unusual behavior and report any concerns to your veterinarian immediately.
  7. For further questions regarding this recall, contact the FDA Center for Veterinary Medicine (CVM) at 1-240-276-9300.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider or veterinarian for guidance on unused products.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Chloramphenicol 0.5% Ophthalmic (10 ML)
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Ciprofloxacin HCL 0.4% Ophthalmic (10 ML)
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Cyclosporine (A) (Cannola Oil) 1% Ophthalmic (10 ML, 15 ML)
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Cyclosporine (A) (Corn Oil) 1% Ophthalmic (5 ML, 10 ML, 15 ML, 20 ML, 30 ML, 40 ML, 60 ML)
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Cyclosporine (A) / Tacrolimus Oil Solution 1%/0.01% Ophthalmic (10 ML)
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Cyclosporine (A) / Tacrolimus Oil Solution 1%/0.02% Ophthalmic
Model:
V-079-2012
Lot Numbers (808):
0387911
0381431
0389075
0401548
0403475
0408637
0394895
0388625
0397986
0360644
0403535
0401573
0387993
0365237
0408756
0361363
0394368
0373042
0356454
0404511
0408900
0394807
0403180
0387393
0377302
0365012
0405621
0394283
0393012
0362963
0362917
0405988
0354948
0397499
0401483
0405649
0356336
0401019
0387353
0398771
0391281
0394295
0395169
0398870
0356129
0354840
0399180
0397548
0395611
0357661
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Cyclosporine Ointment 0.1% Ophthalmic
Model:
V-080-2012
Lot Numbers (221):
0399876
0406303
0369646
0374463
0389926
0400266
0370082
0389688
0388384
0404678
0394310
0387718
0391476
0402038
0361990
0377727
0397981
0356342
0393409
0381097
0403636
0368797
0410154
0382649
0396930
0386183
0396066
0397879
0404517
0366567
0363856
0407628
0404481
0358269
0402749
0391242
0403564
0399026
0398049
0397141
0395731
0394992
0399187
037584
0408781
0394593
0397045
0391549
0394563
0381995
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Demecarium Bromide Ophthalmic in Artificial Tears 0.25%
Model:
V-081-2012
Lot Numbers:
0392042
0396445
0405722
0404274
0388995
0389316
0391240
0393461
0388057
0381667
0368803
0400485
0387763
0401511
0398728
0388724
0404803
0389669
0393532
0380503
0386380
0406901
0395425
0402583
0404765
0397451
0387755
0391791
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Clotrimazole Uterine Flush
Model:
V-082-2012
Lot Numbers:
0357765
0401780
0400714
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Amikacin Sulfate Otic / Tobramycin Drops
Model:
V-083-2012
Lot Numbers:
0390908
0406310
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Cyproheptadine / Cimetidine / Cyclosporine Oral Products
Model:
V-084-2012
Lot Numbers:
0403923
0408603
0387967
0410446
0406448
0394139
0404077
0354257
0397364
0397982
0408059
0363809
0400105
0408064
0410356
0383051
0369505
0365163
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Mitomycin Ophthalmic Injectable PF 5MG/ML
Model:
V-085-2012
Lot Numbers:
0398948
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Carboxymethylcellulose Sterile Liquid
Model:
V-086-2012
Lot Numbers:
0363639
0406218
0359530
0353354
0390217
0359380
Date Ranges: Distributed between 11/21/2011 and 05/21/2012
Product: Medical Devices: Needles, Inject-Ease, Syringes
Model:
V-087-2012
Lot Numbers:
0372951
0406960
0406808
0407647
Date Ranges: Distributed between 11/21/2011 and 05/21/2012

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 62008
Status: Resolved
Manufacturer: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Sold By: Veterinary Clinics; Veterinarians
Manufactured In: United States
Units Affected: 9 products (1186; 377; 50; 5; 2; 45; 2; 13; 4)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response