FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0150-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0145-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0135-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0125-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0120-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0117-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0115-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0113-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0112-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0110-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0155-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0140-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0130-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0105-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01
by Advantice Health, Llc
- Reason
- Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
- Published
- March 1, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11
by Amerisource Health Services LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- February 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
by Leadiant Biosciences, Inc.
- Reason
- Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
- Published
- February 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
by Consolidated Chemical, Inc
- Reason
- CGMP Deviations: initiated due to violations of CGMP manufacturing practices
- Published
- February 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
by Consolidated Chemical, Inc
- Reason
- CGMP Deviations: initiated due to violations of CGMP manufacturing practices
- Published
- February 22, 2023
- 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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