FDA Recalls HCG and Methylcobalamin Injection Due to Sterility Concerns
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections nationwide because FDA inspections found violations that may have compromised product 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 for significant quality and sterility concerns in injectable medications.
Plain-English summary
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vials. The recall covers 3,120 ml of product distributed nationwide between November 2014 and May 2015. Specific lots were distributed with expiration dates ranging from May 22, 2015, to July 5, 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raised concerns about the assurance of sterility and potentially impacted the overall quality of the product.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 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
- 04152015@15
- 6/14/2015
- 03232015@64
- 5/22/2015
- 04222015@68
- 6/21/2015
- 04272015@86
- 6/26/2015
- 04292015@62
- 6/28/2015
- 05062015@5
- 7/5/2015
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.
See all 382 products in this recall →Related recalls
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