Drug Recall
Terminated
Historical recordClass II
Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
by Pharm D Solutions, LLC
- Reason
- Lack of Assurance of Sterility
- Recall initiated
- September 10, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of assurance of sterility
- Recall initiated
- October 19, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- U.S.A. nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass II
Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of assurance of sterility
- Recall initiated
- October 19, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- U.S.A. nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass II
Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of assurance of sterility
- Recall initiated
- October 19, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- U.S.A. nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass II
Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of assurance of sterility
- Recall initiated
- October 19, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- U.S.A. nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass II
Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of assurance of sterility
- Recall initiated
- October 19, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- U.S.A. nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass II
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: OOS resultsduring routine stability testing
- Recall initiated
- October 22, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Distributed nationwide in the USA and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass II
Irbesartan Bulk Active Pharmaceutical Ingredient.
by Aurobindo Pharma Limited (Unit I)
- Reason
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Recall initiated
- October 24, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Product was distributed to one customer in NY.
View recall →
Drug Recall
Terminated
Historical recordClass II
Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0004-1
by Sprayology
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Recall initiated
- October 9, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Distributed Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical recordClass II
Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1
by Sprayology
- Reason
- CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- Recall initiated
- October 9, 2018
- Reported by FDA
- November 7, 2018
- Distribution
- Distributed Nationwide in the USA
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
