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BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEP...

FDA Drug Recall #D-1470-2012 — Class II — May 25, 2012

Recall Summary

Recall Number D-1470-2012
Classification Class II — Moderate risk
Date Initiated May 25, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Location Ocala, FL
Product Type Drugs
Quantity 79 units

Product Description

BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML, 250 ML, 300 ML, 500 ML, 60 ML; BUPIVACAINE HCL 0.5% INJECTABLE1000 ML, 120 ML, 200 ML, 250 ML, 400 ML, 50 ML, 500 ML, 600 ML, 750 ML; BUPIVACAINE HCL, P.F. 0.25% INJECTABLE 1000 ML, 120 ML, 1200 ML, 150 ML, 1500 ML, 180 ML, 240 ML, 300 ML, 60 ML, 600 ML, 900 ML; BUPIVACAINE HCL, P.F. 0.5% INJECTABLE 10 ML, 120 ML, 1500 ML, 20 ML, 200 ML, 240 ML, 2500 ML, 300 ML, 360 ML, 600 ML, 960 ML; BUPIVACAINE HCL, P.F. 0.75% INJECTABLE 1200 ML, 150 ML, 240 ML, 30 ML, 600 ML, 7 ML (47 DIFFERENT PRODUCTS)

Reason for Recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Distribution Pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

Lot / Code Information

Rx #'s: 0402964 0402963 0398083 0398557 0398524 0406883 0396497 0401829 0407441 0408458 0408393 0398196 0398084 0405518 0397074 0401694 0401412 0398196 0404325 0397888 0407444 0408529 0408099 0401897 0402614 0405996 0402614 0405382 0398014 0398022 0400197 0400116 0400197 0401897 0405996 0398014 0402614 0398014 0401755 0401755 0404391 0402616 0401688 0398026 0399744 0402617 0398026 0401755 0398026 0402616 0400850 0404643 0408996 0403960 0400509 0400960 0403759 0404643 0405771

Other Recalls from Franck's Lab Inc., d.b.a. Franck's Co...

Recall # Classification Product Date
D-1513-2012 Class II ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PR... May 25, 2012
D-1452-2012 Class II ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, ... May 25, 2012
D-1514-2012 Class II EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJ... May 25, 2012
D-1451-2012 Class II AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16"... May 25, 2012
D-1492-2012 Class II CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%... May 25, 2012

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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