FDA Recall
Terminated
Historical recordClass II
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
by Novitium Pharma LLC
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
by Lannett Company, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- November 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
by ICU Medical Inc
- Reason
- Presence of Particulate Matter.
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
by ICU Medical Inc
- Reason
- Presence of Particulate Matter.
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.
by Sato Pharmaceutical Inc.
- Reason
- Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx
by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- November 13, 2019
- 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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