Betamethasone Sodium Phosphate Injectable Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Betamethasone Sodium Phosphate injectable due to FDA inspection findings of GMP violations that may impact 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 drug.
Plain-English summary
The Compounding Pharmacy of America is recalling Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable. 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 was distributed nationwide between November 2014 and May 2015. The specific lot code is 12122015@76, with a date of 6/10/2015. The quantity involved is 13 ml.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Steroid
- 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 (3)
- All lots distributed between November 2014 and May 2015
- 12122015@76
- 6/10/2015
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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