FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility; product has the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
by SCA Pharmaceuticals
- Reason
- Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Raja Foods, L.L.C.
- Product
- Anarkali Peshawari Naan Bread Frozen 15oz. retail plastic p…
- Reason
- Undeclared milk
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Peanut Butter holdings, LLC
- Product
- PB Crave, Coconut Milk Chocolate Peanut Butter Spread, NET W…
- Reason
- Product mislabeled. "'Contains " allergen statement under the ingredient list fails to list coconut.
- Published
- August 2, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Beatrice Bakery Co
- Product
- 1) Key Lime Dessert Cake, Grandma's Bake Shoppe, NET WT. 14…
- Reason
- Product contains certified colors Blue 1 and Yellow 5 which are incorrectly declared as "green color (vegetable and turmeric)."
- Published
- August 2, 2017
- Distribution
- The recalled product was sold in the fir…
View recall →
FDA Recall
Terminated
Historical recordClass III
Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Published
- July 26, 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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