US Compounding Recalls Neostigmine Syringes Due to Sterility Concerns
US Compounding Inc is recalling 15,640 vials of Neostigmine 5 mg/5 mL syringes nationwide due to deficient practices that may impact sterility assurance.
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, FDA Class II recalls with potential for adverse health consequences (such as sterility assurance failures in injectable drugs) are categorized as Severe.
Plain-English summary
US Compounding Inc is voluntarily recalling 15,640 single-use syringes of Neostigmine (5 mg/5 mL) for IM, SC, or slow IV injection. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide. The recall is being conducted because of deficient practices that may have an impact on the assurance of sterility for these preparations.
The affected products are identified by specific lot codes and expiration dates, including lots 20150106@48, 20150106@49, 20150306@37, 20150906@50, 20150906@7, 20151208@32, 20152304@2, and 20152804@6. The expiration dates for these lots range from October 20, 2015, to February 8, 2016.
Healthcare providers and patients should stop using the recalled Neostigmine syringes and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 15,640
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 (8)
- Lot Code: 20150106@48 BUD: 11/28/2015
- 20150106@49 BUD: 11/28/2015
- 20150306@37 BUD: 11/30/2015
- 20150906@50 BUD: 12/6/2015
- 20150906@7 BUD: 12/5/2015
- 20151208@32 BUD: 2/8/2016
- 20152304@2 BUD: 10/20/2015
- 20152804@6 BUD:10/24/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding 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.
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