The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-349-2013·Announced 2013-05-22

FDA Recalls Betamethasone Injection Due to Sterility Assurance Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Betamethasone Combination with Lidocaine and Bupivacaine Injection due to lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, an FDA Class II recall involving a sterile product with sterility assurance concerns is categorized as Severe (Score 4) due to the potential for significant injury from infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection. The recall covers all strengths and presentations, including Betameth combo 6 mg/mL lido 1% bup 0.5% syr and Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr. The product is prescription-only and was distributed nationwide.

The recall is being conducted due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. This decision follows concerns associated with the facility's quality control processes.

Patients who have received this medication should contact their healthcare provider for further instructions. The specific lot numbers and expiration dates are listed in the structured product information.

The recalled product

Product
Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Sterile Product
Hazard
Affected units
270

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 (6)

  • Lot #: a) Betameth combo 6mg/ml lido1% bup 0.5% syr: 13021975
  • Exp 5/19/2013
  • b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr: 13012550
  • Exp 4/25/2013
  • 130215100
  • Exp 5/15/2013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs 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 78 products in this recall →

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