FDA Recall
Terminated
Historical recordClass II
PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass II
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Reason
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Published
- April 17, 2019
- Distribution
- Dispensed in Oregon
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
by Auro Pharmacies Inc. DBA Central Drugs
- Reason
- Failed pH Specification: product does not meet pH label claim.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Theo Chocolate Inc
- Product
- Sea Salt 70% Dark Chocolate 3 oz. bars, wrapped in foil and…
- Reason
- Theo Chocolate Sea Salt 70% Dark Chocolate Bar is recalled due to undeclared milk.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GOOD KARMA FOODS INC
- Product
- PL Trader Joe Natural Creamer - Vanilla 12/32oz, Plastic bot…
- Reason
- Product was recalled due to undeclared milk. The Contains statement does not list milk as an ingredient.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Merical, LLC
- Product
- Walgreens Probiotic 12.5 Billion Active Cultures, 30 capsule…
- Reason
- Incorrect probiotic strain used in formulation which did not match product labeling.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Label mix-up
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
by KRS Global Biotechnology, Inc
- Reason
- Labeling: Label mix-up
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
by Johnson Matthey Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
- Published
- April 10, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
by Pfizer Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Published
- April 10, 2019
- 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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