FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- PRIVATE SELECTION FROZEN BLACKBERRIES in 16 oz. bags, 10 bag…
- Reason
- Potential norovirus contamination.
- Published
- April 15, 2020
- Distribution
- Product was distributed to the following…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- PRIVATE SELECTION FROZEN BERRY MEDLEY in 16 oz. (10 bags per…
- Reason
- Potential norovirus contamination.
- Published
- April 15, 2020
- Distribution
- Product was distributed to the following…
View recall →
FDA Recall
Terminated
Historical recordClass III
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
by Akorn Inc
- Reason
- Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Defective Container: Recall is due to breaking and shattering of ampules upon opening
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Advanced Fresh Concepts Corp
- Product
- Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp; Tray +0…
- Reason
- Firm testing found Vibrio parahaemolyticus in cooked butterfly shrimp from Thailand.
- Published
- April 8, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
New Capstone, Inc
- Product
- ReStructure VANILLA PROTEIN POWDER NET WT. 527G POUCH & 27G…
- Reason
- The firm was notified that the labeling does not include the word milk on the ingredient statement
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- SubPotent Drug: Low out-of-specification results for assay testing.
- Published
- April 1, 2020
- 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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