Drug Recall
Terminated
Historical recordClass II
Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5.
by Keystone Laboratories Inc
- Reason
- Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
- Recall initiated
- February 8, 2016
- Reported by FDA
- March 2, 2016
- Distribution
- Nationwide and Canada
View recall →
Drug Recall
Terminated
Historical recordClass III
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
- Recall initiated
- January 14, 2016
- Reported by FDA
- March 2, 2016
- Distribution
- US Nationwide including Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass I
fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Recall initiated
- January 13, 2015
- Reported by FDA
- February 24, 2016
- Distribution
- Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
View recall →
Drug Recall
Terminated
Historical recordClass I
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Recall initiated
- January 13, 2015
- Reported by FDA
- February 24, 2016
- Distribution
- Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
View recall →
Drug Recall
Terminated
Historical recordClass I
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
by Fit Firm and Fabulous
- Reason
- Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.
- Recall initiated
- September 29, 2015
- Reported by FDA
- February 24, 2016
- Distribution
- Nationwide in the U.S.A. via the website.
View recall →
Drug Recall
Terminated
Historical recordClass III
Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
- Recall initiated
- November 4, 2015
- Reported by FDA
- February 24, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
- Recall initiated
- November 4, 2015
- Reported by FDA
- February 24, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
- Recall initiated
- November 4, 2015
- Reported by FDA
- February 24, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
View recall →
Drug Recall
Terminated
Historical recordClass II
papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
by Abbott's Compounding Pharmacy, Inc.
- Reason
- Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
- Recall initiated
- January 15, 2016
- Reported by FDA
- February 24, 2016
- Distribution
- CA
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.
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