The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0797-2016·Announced 2016-04-06

Walter's Pharmacy Recalls Vancomycin Solution Due to Sterility Concerns

Walter's Pharmacy is recalling Vancomycin 50mg/mL Solution because there is a lack of assurance of sterility. The recall affects 10mL bottles 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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable medication warrants a score of 4 (Severe), as it poses a risk of serious adverse health consequences.

Plain-English summary

Walter's Pharmacy is recalling Vancomycin 50mg/mL Solution, 10mL bottles, prescription only. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by Lot # 020216 and NDC 99999-9991-54.

The recall is limited to products distributed in Pennsylvania. Walter's Pharmacy is the recalling firm and the manufacturer of the affected product.

Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed.

The recalled product

Product
Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
Manufacturer
Walter's Pharmacy
Category
Drug — Antibiotic
Hazard
Affected units
1

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 (1)

  • Lot #: 020216

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 →

Related recalls

Same manufacturer · Walter's Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls