FDA Recall
Terminated
Historical recordClass II
FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
by Key Pharmacy and Compounding Center
- Reason
- Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Herbalife International Of America Inc
- Product
- Protein Bar 14 bars/box, Net Wt. 19.74oz (560g) Each ship…
- Reason
- Herbalife is recalling Protein Bar-Peanut Butter because it may contain a trace amount of fish gelatin.
- Published
- May 24, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel
by Teva Pharmaceuticals USA
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
by Teva Pharmaceuticals USA
- Reason
- Failed Stability Specifications
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
by Par Sterile Products LLC
- Reason
- Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
by Akorn, Inc.
- Reason
- Product is being recalled due to low pH value.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 32 count Miss Vickies Multipack Box 44 oz. packaged in flexi…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- 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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