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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 474568, Irregulars Breaded Cod 2 oz. 10 Grain…
- Reason
- Irregulars Breaded Cod 2 oz. 10 Grain Cod product is recalled because it may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 474568, Irregulars Battered Cod 3 oz Battered…
- Reason
- Irregulars Battered Cod 3 oz Battered Diamonds is recalled because it may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 17116, Alaska Cod Rectangles 3 oz,Crunchy Bre…
- Reason
- Alaska Cod Rectangles 3 oz is recalled because it may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 16582, Alaska Cod Rectangles 4 oz, Raw Breade…
- Reason
- Alaska Cod Rectangles 4 oz product is recalled because they may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 16596, Alaska Cod Diamond Cut 3 oz, English S…
- Reason
- Alaska Cod Diamond Cut Squares 3 oz product is recalled because they may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 16595, Alaska Cod Squares 4 oz, raw breaded p…
- Reason
- Alaska Cod Squares 4 oz product is recalled because they may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 38520, Panko Breaded Alaska Cod, 4 oz. Square…
- Reason
- Panko Breaded Alaska Cod 4 oz. product is recalled because it may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trident Seafoods Corp - Island Enterprise M/V
- Product
- Trident Item # 421048, Multi-Grain Alaskan Cod, Frozen, RETA…
- Reason
- Multi-Grain Alaskan Cod, Frozen product, retail 12 oz. packages are recalled because they may contain small pieces of plastic.
- Published
- June 7, 2017
- Distribution
- distributed in AK, AL, AZ, CA, CO, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tyson Foods, inc.
- Product
- Sara Lee CP Quiche 10 Spinach , 38 oz. packed in a paper car…
- Reason
- The firm is voluntarily recalling multiple lots of frozen Chef Pierre 10 Spinach Quiche, Chef Pierre 6/10 Frozen Quiche, and Sara Lee CP Quiche 10 Spinach following an ingredient supplier's recall due to Listeria monocytogenes.
- Published
- June 7, 2017
- Distribution
- Domestic only: FL,GA, IA, IL, KY, TX, MI…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tyson Foods, inc.
- Product
- Chef Pierre 10 Spinach Quiche, and 6/10 Frozen Quiche, 38 oz…
- Reason
- The firm is voluntarily recalling multiple lots of frozen Chef Pierre 10 Spinach Quiche, Chef Pierre 6/10 Frozen Quiche, and Sara Lee CP Quiche 10 Spinach following an ingredient supplier's recall due to Listeria monocytogenes.
- Published
- June 7, 2017
- Distribution
- Domestic only: FL,GA, IA, IL, KY, TX, MI…
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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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