The Recall Desk
SevereFDA (Drugs)·D-1507-2019·Announced 2019-07-31

Pharma-Natural Recalls Workvie Pain Roll-On for Manufacturing Violations

Pharma-Natural Inc. is recalling Workvie Instant Pain Relieving Roll On due to current good manufacturing practice deviations, including lack of process and cleaning validation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), as it represents a situation where use of the product could result in temporary or medically reversible adverse health consequences.

Plain-English summary

Pharma-Natural Inc. is recalling 5,273 bottles of Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g). The product is distributed by Marketite, LLC. in Coral Gables, FL, and carries NDC 72393-201-25. All lots remaining within their expiry date are affected.

The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the products were manufactured with a lack of process validation, cleaning validation, stability studies, and other CGMP violations. The FDA has classified this recall as Class II.

The product was distributed to consignees in Florida and Texas, who may have further distributed it nationwide in the USA and Puerto Rico. Consumers should stop using the product and contact the distributor or manufacturer for instructions on return or disposal.

The recalled product

Product
Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
Manufacturer
Pharma-Natural Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
5,273

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 16 recalled by Pharma-Natural Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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