FDA Recall
Terminated
Historical recordClass I
SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620
by Fresenius Kabi USA, LLC
- Reason
- Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610
by Fresenius Kabi USA, LLC
- Reason
- Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
by Aurobindo Pharma USA Inc.
- Reason
- Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Agropur MSI Ingredients LLC
- Product
- Jay Robb Unflavored Egg White Protein, Net Weight 24 oz (1.5…
- Reason
- JayRobb Unflavored Egg White Protein Product is being recalled due to undeclared milk.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Rich Products Corp
- Product
- VANILLA WHIPPED ICING ARTIFICALLY FLAVORED Product Number: 0…
- Reason
- Possible contamination with cleaning chemicals.
- Published
- December 12, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1
by Ascend Laboratories LLC
- Reason
- Presence of Foreign Substance; metal shard found in tablet
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Signature Confetti Cake cake mix 15.25oz.…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Butter Golden cake mix 15.25oz. 12…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Classic Yellow cake mix 15.25oz. 1…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Duncan Hines Classic Classic White cake mix 15.25oz. 12…
- Reason
- positive finding of Salmonella in a retail sample
- Published
- December 5, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
by American Health Packaging
- Reason
- Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- 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.
Read the full medical disclaimer.