Agency classClass IIOur severity:Severe FDA (Drugs)·D-1522-2015·Announced 2015-09-23

HCG Injection Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection vials nationwide because an FDA inspection identified GMP violations that may impact sterility.

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 involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The recall covers 1,043 ml of product distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on return or disposal.

The recalled product

Product: HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility
gmp-violation

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)

All lots distributed between November 2014 and May 2015
05072015@2
7/6/2015
04082015@25
6/7/2015
03042015@54
6/2/2015
04142015@16
6/13/2015
03312015@37
5/30/2015
04062015@75
6/5/2015
05112015@15
7/10/2015
04272015@21
6/26/2015
04272015@62

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 →

Same manufacturer · The Compounding Pharmacy of America

See all →

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Morphine and Bupivacaine Solution Recalled for Sterility Concerns
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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility