BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT)
Reported: August 22, 2012 Initiated: May 25, 2012 #D-1473-2012
Product Description
BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT)
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.
Details
- Recalling Firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Units Affected
- 1 unit
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Location
- Ocala, FL
Frequently Asked Questions
What product was recalled? ▼
BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT). Recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab. Units affected: 1 unit.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 22, 2012. Severity: Moderate. Recall number: D-1473-2012.
Related Recalls
FDA Drug Moderate
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…
Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…
Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…
Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical
Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC · 2026-02-11