FDA Recall
Terminated
Historical recordClass II
HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
by Clinical Specialties Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 10, 2013
- Distribution
- FL, GA and SC.
View recall →
FDA Recall
Terminated
Historical recordClass III
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11
by Pfizer Inc.
- Reason
- Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11
by Pfizer Inc.
- Reason
- Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
- Published
- July 10, 2013
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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