Green Valley Drugs Recalls BET-ACE-LIDO-6-2 Injection Due to Sterility Concerns
Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection products because the pharmacy could not ensure the sterility of the compounded items.
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 and involves a lack of sterility assurance for injectable products, which poses a significant risk of serious injury or death from infection.
Plain-English summary
FVS Holdings, Inc. dba. Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection, all strengths and presentations, including 7 mL syringes and Betameth Combo 6 mg/mL Lidocaine 2% Syringes. The recall involves 435 vials and syringes that were distributed nationwide.
The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes at the facility.
Affected lots include 13012320-GV1, 13021840GV1, 13031150GV1, and 13011532, with expiration dates ranging from April 15, 2013, to June 11, 2013. Consumers and healthcare providers should stop using these products and contact their healthcare provider for further instructions.
The recalled product
- Product
- BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Affected units
- 435
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 (9)
- Lot #: 13012320-GV1
- Exp 4/23/2013
- 13021840GV1
- Exp 5/18/2013
- 13031150GV1
- Exp 6/11/2013
- 13012320-GV1
- 13011532
- Exp 4/15/2013.
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 →Related recalls
Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs
See all →- SevereGreen Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SevereGreen Valley Drugs Recalls Phosphatidylcholine Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SevereFDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-05-22
- SevereGreen Valley Drugs Recalls Thiamine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SevereGreen Valley Drugs Recalls Folic Acid Injections Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- CriticalGreen Valley Drugs Recalls Cyanocobalamin Injection Due to Sterility Failure
FDA (Drugs) · 2013-05-22
- SeverePharmakon Recalls Lidocaine Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-07-20
- CriticalGreen Valley Drugs Recalls Methylprednisolone Injectable Suspension Due to Sterility Failure
FDA (Drugs) · 2013-05-22
- SevereLeiter's Pharmacy Recalls Lidocaine/Phenylephrine Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- HighMitomycin Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-11-09
- SevereBetamethasone Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2013-05-01