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Class II: temporary or reversible health riskTerminated

Medaus M.I.C. 25/50/50 Recall

M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials,…

Medaus, Inc. · Birmingham, AL

Risk level
Class II
Reported by FDA
Jul 20, 2016
Recall ID
D-1220-2016
Check your lot numberHow we source this data

Summary

Medaus recalled M.I.C. 25/50/50 starting May 13, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1220-2016 on Jul 20, 2016. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY

Lot numbers, UPCs & expiration codes

Lot #: 151130-48, BUD: 05/26/16; Lot #: 151215-7, BUD: 05/26/16; Lot #: 151216-12, BUD: 05/26/16; Lot #: 160106-27, BUD: 05/26/16; Lot #: 160113-38, BUD: 07/11/16; Lot #: 160223-33, BUD: 07/31/16; Lot #: 160307-36, BUD: 07/31/16; Lot #: 160307-52, BUD: 07/31/16; Lot #: 160308-5, BUD: 07/31/16

Where it was sold

U.S. Nationwide, Japan, and New Zealand.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1220-2016
Classification
Class II
Status
Terminated
Recall initiated
May 13, 2016
FDA report date
Jul 20, 2016
Quantity
187 mL in Vials
Recall type
Voluntary: Firm initiated
Recalling firm
Medaus, Inc.

Original FDA data

Every field from FDA enforcement report D-1220-2016, exactly as published.

Show all FDA fields
City
Birmingham
State
AL
Status
Terminated
Country
United States
Event ID
74466
Address
6801 Cahaba Valley Rd Ste 116
Code information
Lot #: 151130-48, BUD: 05/26/16; Lot #: 151215-7, BUD: 05/26/16; Lot #: 151216-12, BUD: 05/26/16; Lot #: 160106-27, BUD: 05/26/16; Lot #: 160113-38, BUD: 07/11/16; Lot #: 160223-33, BUD: 07/31/16; Lot #: 160307-36, BUD: 07/31/16; Lot #: 160307-52, BUD: 07/31/16; Lot #: 160308-5, BUD: 07/31/16
Postal code
35242-9609
Report date
Jul 20, 2016
Product type
Drugs
Recall number
D-1220-2016
Classification
Class II
Recalling firm
Medaus, Inc.
Product quantity
187 mL in Vials
Termination date
Jun 16, 2017
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY
Distribution pattern
U.S. Nationwide, Japan, and New Zealand.
Recall initiation date
May 13, 2016
Initial firm notification
E-Mail
Center classification date
Jul 8, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1220-2016, published Jul 20, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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