Class I - Dangerous
Lack of assurance of sterility.
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Other Drugs
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alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
The Hain Celestial Group, Inc. - Worldwide HQ
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
PharMEDium Services
Class I - Dangerous
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
PharMEDium Services
Class I - Dangerous
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
World Organix
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Class I - Dangerous
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
Longbow First Aid Products Manufactory
Class I - Dangerous
CGMP Deviations
Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
Longbow First Aid Products Manufactory
Class I - Dangerous
CGMP Deviations
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-63
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility: Potential leakage of bags.
alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.
The Hain Celestial Group, Inc. - Worldwide HQ
Class I - Dangerous
Incorrect Product Formulation: wrong sunscreen product in the package.