Morphine Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Morphine 30 mg/ml Solution because an FDA inspection found GMP violations that may affect sterility.
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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an injectable medication.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 30 mg/ml Solution, Sterile-Preservative Free. The recall covers 359 ml units distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the official recall notice.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. There is a lack of assurance that the product is sterile.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- 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 (13)
- All lots distributed between November 2014 and May 2015
- 02252015@3
- 5/26/2015
- 03022015@17
- 5/31/2015
- 03162015@60
- 6/14/2015
- 04012015@1
- 6/30/2015
- 04142015@66
- 7/13/2015
- 04272015@28
- 6/26/2015
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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