FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Pinnacle Foods, LLC
- Product
- AUNT JEMIMA(R) 14 BLUEBERRY WAFFLES, NET WT 17.18oz UPC 0196…
- Reason
- Potential for Listeria monocytogenes contamination
- Published
- June 14, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmaceuticals, Inc. subsidiary of Forest Laboratories, LLC, Cincinnati OH 45209 USA --- NDC 0456-2410-60; Shellpack containing 1 blister card --- NDC 0456-2410-06
by Forest Laboratories, LLC
- Reason
- Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
- Published
- June 7, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
by SCA Pharmaceuticals
- Reason
- Lack of assurance of sterility: Product bags leaking at seam.
- Published
- June 7, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
by VistaPharm, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
- Published
- June 7, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
LaBri's Body Health Atomic, 60 capsules
by Envy Me
- Reason
- Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
by Gentell, Inc
- Reason
- GMP Deviations; product may not meet cGMP requirements
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.
by Standard Homeopathic Company
- Reason
- Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Reason
- Superpotent Drug: above specification for the assay.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 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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