Agency classClass IIOur severity:Severe FDA (Drugs)·D-646-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Hydroxyprogesterone Due to Sterility Concerns

Clinical Specialties Compounding Pharmacy is recalling Hydroxyprogesterone 250 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

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, which corresponds to a 'Severe' rating under the rubric for drug recalls involving potential health risks.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling specific lots of Hydroxyprogesterone 250 mg/ml. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes used to ensure the sterility of the product.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific lots subject to the recall include Lot number CABDAIAB:64 (Exp date: 4/8/2013), Lot number CABDAEAB:21 (Exp date: 4/4/2013), Lot number CABDBIAB:75 (Exp date: 4/18/2013), Lot number CABDAEAC:00 (Exp date: 5/5/2013), and Lot number CABDJAC:67 (Exp date: 5/20/2013).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If you have this product, you should stop using it and contact the recalling firm or your healthcare provider for further instructions.

The recalled product

Product: Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer: Clinical Specialties Compounding Pharmacy
Category: Drug — Compounded Medication
Hazard: sterility
quality-control

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)

Lot number CABDAIAB:64
Exp date: 4/8/2013
Lot number CABDAEAB:21
Exp date: 4/4/2013
Lot number CABDBIAB:75
Exp date: 4/18/2013
Lot number CABDAEAC:00
Exp date: 5/5/2013 and Lot number CABDJAC:67
Exp date: 5/20/2013.

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy 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 49 products in this recall →

Same manufacturer · Clinical Specialties Compounding Pharmacy

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