FDA Recall
Terminated
Historical recordClass I
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
by Advanced Pharma Inc.
- Reason
- Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
by Advanced Pharma Inc.
- Reason
- Subpotent Drug: found to be below the specification for labeled assay.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
by Osmotica Pharmaceutical Corp
- Reason
- Subpotent Drug
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
by Osmotica Pharmaceutical Corp
- Reason
- Subpotent Drug
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Aldi Inc
- Product
- Choceur Dark Chocolate Bars, 5.29 oz., 20 units/case
- Reason
- ALDI has voluntarily recalled Choceur Dark Chocolate Bars due to the potential presence of almond pieces, which are an undeclared treenut allergen.
- Published
- December 27, 2017
- Distribution
- Domestic: OH, IN, WI, NY, MI, IL, MD, CT…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Creative Contract Packaging Corporation, LLC
- Product
- HERB-OX Beef Flavor Granulated Bouillon, 4 ounce jars
- Reason
- Creative Contract Packaging LLC is voluntarily recalling two code dates of HERB-OX Beef Flavor Granulated Bouillon, due to the potential presence of an undeclared milk allergen.
- Published
- December 27, 2017
- Distribution
- Domestic: AZ, CA, CO, CT, DE, IA,ID, IN,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512
by Sun Pharmaceutical Industries, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 20, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
- Published
- December 20, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Colorado Nut Co
- Product
- Frontier Trail Mix (4 oz. bag), UPC 018142352987. Packaged i…
- Reason
- Undeclared milk in snack mix products
- Published
- December 20, 2017
- Distribution
- Product distributed distributors and ret…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Colorado Nut Co
- Product
- Peanut Delight (8 oz. bag), UPC 018142352512. Packaged in Pl…
- Reason
- Undeclared milk in snack mix products
- Published
- December 20, 2017
- Distribution
- Product distributed distributors and ret…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Colorado Nut Co
- Product
- Honey Nutty Granola (8 oz. bag), UPC 018142352147. Packaged…
- Reason
- Undeclared milk in snack mix products
- Published
- December 20, 2017
- Distribution
- Product distributed distributors and ret…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Colorado Nut Co
- Product
- Oat Bran Nutty Crunch (8 oz. bag), UPC 018142352130. Package…
- Reason
- Undeclared milk in snack mix products
- Published
- December 20, 2017
- Distribution
- Product distributed distributors and ret…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Colorado Nut Co
- Product
- Cashew Cranberry Cherry Jubilee (8 oz. bag), UPC 01814235216…
- Reason
- Undeclared milk in snack mix products
- Published
- December 20, 2017
- Distribution
- Product distributed distributors and ret…
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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