FDA Recall
🇺🇸 United States
TerminatedTerminated: June 23, 2023Historical recordClass II
Alpenland International, Inc.
- Product
- HEILEMANN CONFISERIE WEHNACHTSFIGUREN AUS EDELVOLLMILCH-SCHO…
- Reason
- The manufacturer informed the firm that they received a complaint of plastic in the product.
- Published
- March 8, 2023
- Distribution
- Product was shipped to the following sta…
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FDA Recall
TerminatedTerminated: June 14, 2024Historical recordClass II
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
by RISING PHARMACEUTICALS
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 1, 2023
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
by B. Braun Medical Inc.
- Reason
- Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
- Published
- March 1, 2023
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
by B. Braun Medical Inc.
- Reason
- Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
- Published
- March 1, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 31, 2023Historical recordClass II
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 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 71858-0160-5
by IBSA PHARMA INC
- Reason
- Subpotent Drug
- Published
- March 1, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
TerminatedTerminated: October 31, 2023Historical 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
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FDA Recall
OngoingHistorical 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
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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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