FDA Recall
Terminated
Historical recordClass II
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014
by Kiriko, LLC.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
- Reason
- Subpotent Drug: low out of specification results.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.
by Sanofi-Aventis U.S. LLC
- Reason
- Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
by AVKARE Inc.
- Reason
- Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Tres Latin Foods
- Product
- Tres Latin Foods Pupusas, Stuffed Corn Tortillas with Black…
- Reason
- Tres Latin Foods is recalling specific code dates of Kale & Pinto Bean 10 oz. Pupusas and Black Bean and Sweet Corn 10 oz. Pupusas due to undeclared milk allergen.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Tres Latin Foods
- Product
- Tres Latin Foods Kale & Pinto Bean pupusas Stuffed Corn Tort…
- Reason
- Tres Latin Foods is recalling specific code dates of Kale & Pinto Bean 10 oz. Pupusas and Black Bean and Sweet Corn 10 oz. Pupusas due to undeclared milk allergen.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC # 0363001726, UPC # 049022889125
by Vi-Jon, Inc.
- Reason
- Failed Stability Specifications
- Published
- November 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
by Teva Pharmaceuticals USA
- Reason
- Failed Dissolution Specifications: Low out of specification results for dissolution.
- Published
- November 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
by Wockhardt Usa Inc.
- Reason
- Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
- Published
- November 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-03
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- November 1, 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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