The Recall Desk
SevereFDA (Drugs)·D-0270-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls Lidocaine HCL Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% Injection because the product lacks assurance of sterility.

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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant potential harm, specifically the lack of assurance of sterility in an injectable medication.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Lidocaine HCL 2% MDV Injection Solution packaged in 50ml vials. The recall is being conducted because the product lacks assurance of sterility.

The affected product includes 6 vials from two specific lots: S07092019DT@20 with an expiration date of 10/9/19, and S07242019DH@08 with an expiration date of 10/24/19. These products were distributed nationwide in the USA.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the pharmacy or the recalling firm for further instructions.

The recalled product

Product
S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx,
Affected units
6

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 (4)

  • Lot #:S07092019DT@20
  • Exp 10/9/19
  • S07242019DH@08
  • Exp 10/24/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 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 100 products in this recall →

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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