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All recalls8,424 total

K
Khee Trading, Inc. — Product is Frozen Half Shell Oysters in 15-16 pound blocks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER Spec: 144PCS; Imported by: Khee Trading

Imported oysters potentially contaminated with Norovirus

S
SUN PHARMACEUTICAL INDUSTRIES INC — Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A.

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

B
Becton Dickinson & Company — 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.

During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

L
Lutronic Corporation — CLARITY II Laser System; Model No. 1110200210.

Reports of devices sparking/popping and potentially burning patients.

A
Abiomed, Inc. — Impella RP with SmartAssist. Product Code: 0046-0035.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

A
Abiomed, Inc. — Impella RP Flex with SmartAssist. Product Code: 1000323.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

A
Abiomed, Inc. — Impella RP. Product Code: 0046-0011.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

B
Beacon Promotions Inc — Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro, 3. Jaxport, Jacksonville Port Au

Undeclared allergens (milk, soy, and peanut)

B
Beacon Promotions Inc — Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugars

Undeclared allergens (milk, soy, and peanut)

G
Gerber Products Company dba Nestle Infant Nutrition — Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 0150009

Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.

Presence of Foreign substance - potential presence of metal particulate matter

G
Granules Pharmaceuticals Inc. — Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceu

Presence of Foreign Tablets/Capsules

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.

Presence of Foreign substance - potential presence of metal particulate matter

R
Radnostix — Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml

Presence of Particulate Matter: Due to production issues

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.

Presence of Foreign substance - potential presence of metal particulate matter

F
F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.

Presence of Foreign substance - potential presence of metal particulate matter

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

M
Mangalm LLC — Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:***Mustard Oil***

Potential adulteration with erucic acid from mustard oil ingredient.

M
Mangalm LLC — Tops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:***Mustard Oil***

Potential adulteration with erucic acid from mustard oil ingredient.

M
Mangalm LLC — Tops GOLD Mixed Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611380 INGREDIENTS:***Mustard Oil*** Tops GOLD Mixed Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288612950

Potential adulteration with erucic acid from mustard oil ingredient.

M
Mangalm LLC — Tops GOLD Lime Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611397 INGREDIENTS:***Mustard Oil***

Potential adulteration with erucic acid from mustard oil ingredient.

M
Mangalm LLC — Tops GOLD Mango Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611373 INGREDIENTS:***Mustard Oil*** Tops GOLD Mango Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288611915;

Potential adulteration with erucic acid from mustard oil ingredient.

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