The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0385-2016·Announced 2015-11-25

Solutions Rx Pharmacy Recalls Budesonide Capsules Due to Penicillin Contamination

Solutions Rx Pharmacy is recalling compounded budesonide nasal rinse capsules due to possible penicillin cross-contamination in the bulk powder.

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 hazard involves penicillin contamination, which poses a risk of severe allergic reactions or anaphylaxis in sensitive individuals, meeting the criteria for a Severe rating.

Plain-English summary

Solutions Rx Pharmacy is recalling 11,712 capsules of c-Budesonide 0.6MG, 60-count bottles, intended for use in nasal rinse or nebulizer. The recall is due to the possible presence of penicillin in the bulk budesonide powder used to compound the prescription capsules.

The affected product was distributed in Alabama, Georgia, Tennessee, and Louisiana. The recall covers multiple lots with expiration dates ranging from May 31, 2015, to June 16, 2015.

Consumers should stop using the product and contact their healthcare provider or the recalling pharmacy for instructions on disposal or replacement.

The recalled product

Product
c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233
Manufacturer
Solutions Rx Pharmacy
Category
Drug — Compounded Prescription
Hazard
Affected units
11,712

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 #: 04-24-2015-D
  • Exp 05/31/15
  • 03-13-2015-C
  • 03-18-2015-F
  • 03-18-2015-G
  • 03-23-2015-C
  • 03-24-2015-C
  • 04-02-2015-G
  • 04-14-2015-F
  • 04-14-2015-G
  • 04-22-2015
  • 05-06-2015-B
  • 05-14-2015-D
  • 05-22-2015-F
  • 05-27-2015-C
  • 06-02-2015-E
  • 06-10-2015-J
  • Exp 06/16/15

Distribution

Distributed in 4 states:

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