The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0793-2016·Announced 2016-04-06

Walter's Pharmacy Recalls Atropine Ophthalmic Solution Due to Sterility Concerns

Walter's Pharmacy is recalling 22 bottles of Atropine 0.01% Ophthalmic Solution in Pennsylvania due to a 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, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in ophthalmic products) fall under the Severe category.

Plain-English summary

Walter's Pharmacy is recalling 22 bottles of Atropine 0.01% Ophthalmic Solution, 15mL, prescription only. The recall was initiated because of a lack of assurance of sterility for the product.

The affected product is identified by NDC 99999-9019-09. The recall includes specific lot numbers: 112015, 112715, 113015, 120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, and 020516. The product was distributed in Pennsylvania.

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

The recalled product

Product
Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
Manufacturer
Walter's Pharmacy
Category
Drug — Ophthalmic Solution
Hazard
Affected units
22

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 (18)

  • Lot #: 112015
  • 112715
  • 113015
  • 120515
  • 120715
  • 121215
  • 121515
  • 122115
  • 010516
  • 010716
  • 010816
  • 011116
  • 012016
  • 012816
  • 012916
  • 020316
  • 020416
  • 020516.

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 · lack of sterility

See all →

Similar recalls