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Tenn South Distillery LLC dba Big Machine Distillery

Tenn South Distillery LLC dba Big Machine Distillery Recalls

All product recalls associated with Tenn South Distillery LLC dba Big Machine Distillery.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4001–4020 of 25002 recalls

Hand Sanitizer (Big Machine Distillery) – Impurity Excess (2023)

CGMP Deviation: impurities exceed allowable limits.

Class IIModerate

FDAJul 10, 2023TN• Tenn South Distillery LLC dba Big Machine Distillery

Procedural kits containing ultrasonic transmission gel, I... (Advance Medical Designs, Inc.) – mislabeling (2023)

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

ASG-001; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide

1...199 200201202 203...1251

Page 201 of 1251Next

• Advance Medical Designs, Inc.

50-GEL20; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP Sys... (Alphatec Spine, Inc. 1950 Camino Vida Roble) – awl instrument adjustable drill butto... (2023)

Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.

High

FDAJul 7, 2023Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

Golf Cars and PTVs (Yamaha) - vehicle safety issue (2023)

This recall involves model year 2023 Golf Car and Personal Transportation vehicles. The vehicles were sold in various colors including white, blue, green and orange. The model name is located on the left and right side of the vehicle and the serial number can be found on the frame under the operator's seat.

High

CPSCJul 6, 2023Nationwide• Yamaha Motor Powered Products Co. LTD., of Japan

Loteprednol Eye Suspension (Sun Pharma) – Potency Issue (2023)

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Class IIILow

FDAJul 5, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Sunitinib Capsules (Teva) – Moisture Limit Failure (2023)

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Class IIModerate

FDAJul 5, 2023Nationwide• Teva Pharmaceuticals USA Inc

Sodium Chloride Injection (B. Braun) – Sterility Leak Risk (2023)

Lack of assurance of sterility: bags have the potential to leak.

Class IIModerate

FDAJul 5, 2023Nationwide• B. Braun Medical Inc.

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size ... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – increased force may be required to re... (2023)

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Moderate

FDAJul 3, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany