The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0792-2016·Announced 2016-04-06

Walter's Pharmacy Recalls Vancomycin Solution Due to Sterility Concerns

Walter's Pharmacy is recalling specific lots of Vancomycin 25mg/mL solution due to a lack of assurance of sterility. The affected products were distributed in Pennsylvania.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injectable solutions.

Plain-English summary

Walter's Pharmacy is recalling four bottles of Vancomycin 25mg/mL Solution, 10 mL bottles, which are prescription-only. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is identified by NDC 99999-9003-78. The specific lot numbers involved in this recall are 012216, 012616, 012816, 020316, and 020616. The distribution pattern for these products was limited to Pennsylvania.

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. Patients who have received this medication should contact their healthcare provider for further instructions.

The recalled product

Product
Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78
Manufacturer
Walter's Pharmacy
Category
Drug — Antibiotic
Hazard
Affected units
4

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 (5)

  • Lot #: 012216
  • 012616
  • 012816
  • 020316
  • 020616

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 13 recalled by Walter's 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 13 products in this recall →

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