FDA Recall
Terminated
Historical recordClass III
23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0
by The Ritedose Corporation
- Reason
- Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
by Vitae Enim Vitae Scientific, Inc.
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
by Vitae Enim Vitae Scientific, Inc.
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
by Vitae Enim Vitae Scientific, Inc.
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
by Vitae Enim Vitae Scientific, Inc.
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
- Published
- April 6, 2022
- Distribution
- Product was distributed in Arkansas, Flo…
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications; during long term stability testing.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications; during long term stability testing.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
by Aurolife Pharma, LLC
- Reason
- Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
by Drug Depot, Inc., dba APS Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
- Published
- April 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Elmer Candy Corp
- Product
- Elmer's Pecan Egg 1oz product wrapped in polypropylene wrap…
- Reason
- Foreign Material on product - Pecan Tree bark
- Published
- April 6, 2022
- Distribution
- AL, AR, FL, KY, LA, MS, TN, and TX
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lehi Valley Trading Co, Inc
- Product
- Woody's Smokehouse brand Yogurt Raisins, 12.3 oz. (348g), cl…
- Reason
- Bags and tubs of yogurt covered raisins contained undeclared peanuts.
- Published
- April 6, 2022
- 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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