The Recall Desk
SevereFDA (Drugs)·D-651-2013·Announced 2013-07-10

Clinical Specialties Compounding Pharmacy Recalls Medroxyprogesterone Due to Sterility Concerns

Clinical Specialties Compounding Pharmacy is recalling Medroxyprogesterone 150 mg/ml injections because FDA inspections raised concerns about quality control and sterility assurance.

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. According to the rubric, FDA Class II recalls with potential for significant health consequences (such as sterility failures in injectable drugs) are categorized as Severe (Score 4), particularly when structural or process defects like lack of sterility assurance are involved.

Plain-English summary

Clinical Specialties Compounding Pharmacy is recalling Medroxyprogesterone 150 mg/ml injections. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.

The affected product is Medroxyprogesterone 150 mg/ml, manufactured by Clinical Specialties Compounding Pharmacy located in Augusta, Georgia. The total quantity involved is 220ml. The product was distributed in Florida, Georgia, and South Carolina. Specific lot numbers and expiration dates are listed in the official recall documentation.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the pharmacy for further instructions. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Manufacturer
Clinical Specialties Compounding Pharmacy
Category
Drug — Injectable Sterile Drug
Hazard
Affected units
220

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 (20)

  • Lot number CABDDBAB:21
  • Exp date: 7/30/2013
  • Lot number CABCBBBA:65
  • Exp date: 4/9/2013
  • Lot number CABCBBBA:77
  • Lot number CABCBBBA:20
  • Lot number CABCCFBA:42
  • Exp date: 4/23/2013
  • Lot number CABCCFBA:59
  • Lot number CABCCFBA:76
  • Lot number CABCCFBA:85
  • Lot number CABCCHBB:28
  • Exp date: 5/23/2013
  • Lot number CABCCHBB:46
  • Lot number CABCCHBB:87
  • Exp date: 5/26/2013
  • Lot number CABCCHBB:30
  • Lot number CABCBJBC:92
  • Exp date: 6/17/2013
  • Lot number CABCBJBC:93

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 →

Related recalls

Same manufacturer · Clinical Specialties Compounding Pharmacy

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Same hazard · sterility failure

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