John W Hollis Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL recall — FDA D-1397-2014
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Complete FDA and NHTSA recall records dated in June 2014.
These records include useful source details for the selected month.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active…
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C…
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed black cod due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the…
Ingredient statement for one lot of Greek Yogurt Spinach Kale dip contains the ingredient statement for spinach dip.
During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C…
Undeclared Yellow #5 & 6 in Marzipan (Pink, Green, Orange).
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed halibut due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the…
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed salmon due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the…
Undeclared Allergen: Egg
T. H. Seafood, Inc., is recalling raw, frozen, vacuum packed rockfish due to labeling instructions that do not direct the consumer to "Keep Frozen-Thaw Under Refrigeration" to control the…
Internal label review found egg is an ingredient of Grano Padano Cheese used in Parmesan Bread Sticks, but not declared in product ingredient statement or allergen statement.
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.
During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C…
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.