Drug Recall
Terminated
Historical recordClass II
COPPER (SULF), 0.4 mg/mL, injectable, 20 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
CHORIONIC GONADOTROPIN, 4000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
CEFTAZIDIME, 2.25mg/0.1mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
BEVACIZUMAB/DEXAMETHASONE, 1.25/0.5 mL, Injectable, 0.05 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070.
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
ASCORBIC ACID (B), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
by Oregon Compounding Centers, Inc. dba Creative Compounds
- Reason
- Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
- Recall initiated
- October 6, 2014
- Reported by FDA
- November 12, 2014
- Distribution
- Oregon, Washington
View recall →
Drug Recall
Terminated
Historical recordClass II
Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1
by Actavis Inc
- Reason
- Subpotent Drug
- Recall initiated
- August 25, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4
by Actavis Inc
- Reason
- Subpotent Drug
- Recall initiated
- August 25, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
by Specialty Compounding, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- August 9, 2013
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
by Specialty Compounding, LLC
- Reason
- Non Sterility: Microbial contamination
- Recall initiated
- August 9, 2013
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass I
CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
by Cubist Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
- Recall initiated
- August 8, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide and Puerto Rico.
View recall →
Drug Recall
Terminated
Historical recordClass II
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01
by West-Ward Pharmaceutical Corp.
- Reason
- Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
- Recall initiated
- October 2, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- GA
View recall →
Drug Recall
Terminated
Historical recordClass II
Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Vancomycin 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
by Martin Avenue Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
- Recall initiated
- August 27, 2014
- Reported by FDA
- November 5, 2014
- Distribution
- Nationwide
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
