Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 20 mg/ml Solution due to FDA inspection findings regarding GMP violations and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 sterility issues in injectable medications are categorized as Severe (Score 4), as they pose a significant risk of infection or injury, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product consists of 130 ml total volumes distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and dates include 03092015@26 (6/7/2015), 03122015@95 (6/10/2015), 04132015@5 (6/12/2015), and 04292015@8 (6/28/2015).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Solution
- Hazard
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 (9)
- All lots distributed between November 2014 and May 2015
- 03092015@26
- 6/7/2015
- 03122015@95
- 6/10/2015
- 04132015@5
- 6/12/2015
- 04292015@8
- 6/28/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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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